AC5 Topical Gel

Dressing, Wound, Drug

Arch Therapeutics, Inc.

The following data is part of a premarket notification filed by Arch Therapeutics, Inc. with the FDA for Ac5 Topical Gel.

Pre-market Notification Details

Device IDK190129
510k NumberK190129
Device Name:AC5 Topical Gel
ClassificationDressing, Wound, Drug
Applicant Arch Therapeutics, Inc. 235 Walnut Street, Suite 6 Framingham,  MA  01702
ContactTerrence Norchi
CorrespondentTerrence Norchi
Arch Therapeutics, Inc. 235 Walnut Street, Suite 6 Framingham,  MA  01702
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 ProductNo
Date Received2019-01-28
Decision Date2020-03-11

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