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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K192527
Device Name Rochal Antimicrobial Wound Gel
Applicant
Rochal Industries, LLC
12000 Network Blvd., Suite B200
San Antonio,  TX  78249
Applicant Contact William J. Coulston
Correspondent
Rochal Industries, LLC
12000 Network Blvd., Suite B200
San Antonio,  TX  78249
Correspondent Contact William J. Coulston
Classification Product Code
FRO  
Date Received09/13/2019
Decision Date 02/07/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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