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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Silk
510(k) Number K162396
Device Name SILK Surgical Suture
Applicant
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact NATALIE HICHAK
Correspondent
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact NATALIE HICHAK
Regulation Number878.5030
Classification Product Code
GAP  
Date Received08/26/2016
Decision Date 11/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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