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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K182733
Device Name Rochal Bioshield Silicone Film
Applicant
Rochal Industries, LLC
12000 Network Blvd, Ste B200
San Antonio,  TX  78249
Applicant Contact William J. Coulston
Correspondent
Rochal Industries, LLC
12000 Network Blvd, Ste B200
San Antonio,  TX  78249
Correspondent Contact William J. Coulston
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/28/2018
Decision Date 06/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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