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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K162759
FOIA Releasable 510(k) K162759
Device Name KeraStat(R) Gel
Applicant
Keranetics, LLC
200 E. First Stree, Box #4, Suite 102
Winston-Salem,  NC  27101
Applicant Contact Luke Burnett
Correspondent
Ppd, LLC
3900 Paramount Pkwy.
Morrisville,  NC  27560
Correspondent Contact KENNETH G. BUTZ
Classification Product Code
KGN  
Date Received09/30/2016
Decision Date 06/02/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02913560
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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