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FDA 510(k) Application Details - K162396
Device Classification Name
Suture, Nonabsorbable, Silk
More FDA Info for this Device
510(K) Number
K162396
Device Name
Suture, Nonabsorbable, Silk
Applicant
TELEFLEX MEDICAL, INC
3015 CARRINGTON MILL BLVD
MORRISVILLE, NC 27560 US
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Contact
NATALIE HICHAK
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Regulation Number
878.5030
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Classification Product Code
GAP
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More FDA Info for this Product Code
Date Received
08/26/2016
Decision Date
11/23/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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