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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 K182681
Device Name AC5 Topical Gel
Applicant
Arch Therapeutics, Inc.
235 Walnut St., Suite 6
Framingham,  MA  01702
Applicant Contact Terrence W. Norchi
Correspondent
Arch Therapeutics, Inc.
235 Walnut St., Suite 6
Framingham,  MA  01702
Correspondent Contact Terrence W. Norchi
Classification Product Code
FRO  
Date Received09/26/2018
Decision Date 12/14/2018
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02704104
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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