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Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Page 1: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 2: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 3: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 4: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 5: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 6: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 7: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 8: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 9: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 10: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 11: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 12: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 13: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 14: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 15: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 16: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 17: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 18: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 19: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 20: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 21: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 22: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 23: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 24: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 25: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 26: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 27: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 28: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 29: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 30: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 31: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 32: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 33: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 34: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 35: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 36: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 37: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 38: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 39: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 40: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 41: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 42: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 43: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 44: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 45: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 46: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 47: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 48: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 49: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 50: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 51: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 52: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

(b)(4) Third Party Testing

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 53: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

(b)(4) Third Party Testing

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 54: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

(b)(4) Third Party Testing

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 55: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

(b)(4) Third Party Testing

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 56: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

(b)(4) Third Party Testing

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 57: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

(b)(4) Third Party Testing

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 58: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

(b)(4) Third Party Testing

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 59: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

(b)(4) Third Party Testing

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 60: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 61: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 62: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 63: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 64: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Page 65: Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID

Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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1 FDA Update - CDRH Markham C. Luke, MD PhD Deputy Director for Clinical Office of Device Evaluation, CDRH, FDA May 15, 2012 NORD Corporate Council

Medical Device Development Tools: FDA CDRH Pilot Program

Lilly Yue, Ph.D.* CDRH, FDA, Rockville MD 20850

Welcome to today's FDA/CDRH Webinar · 1 Welcome to today’s FDA/CDRH Webinar Thank you for your patience while we register all of today’s participants. If you have not connected

Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at [email protected]

DHHS / FDA / CDRH 1 FDA Summary CryoLife BioGlue P010003 Lead FDA Reviewer Lisa Kennell

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