Rochal Antimicrobial Wound Gel

Dressing, Wound, Drug

Rochal Industries, LLC

The following data is part of a premarket notification filed by Rochal Industries, Llc with the FDA for Rochal Antimicrobial Wound Gel.

Pre-market Notification Details

Device IDK192527
510k NumberK192527
Device Name:Rochal Antimicrobial Wound Gel
ClassificationDressing, Wound, Drug
Applicant Rochal Industries, LLC 12000 Network Blvd, Ste B200 San Antonio,  TX  78249
ContactWilliam J. Coulston
CorrespondentWilliam J. Coulston
Rochal Industries, LLC 12000 Network Blvd, Ste B200 San Antonio,  TX  78249
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-09-13
Decision Date2020-02-07

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