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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 K192386
Device Name KeraStat Cream
Applicant
Keranetics
200 E. First St., Suite 101, Box#4
Winston Salem,  NC  27101
Applicant Contact Luke Burnett
Correspondent
Keranetics
200 E. First St., Suite 101, Box#4
Winston Salem,  NC  27101
Correspondent Contact Luke Burnett
Classification Product Code
KGN  
Date Received09/03/2019
Decision Date 07/16/2020
Decision Substantially Equivalent (SESE)
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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