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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mask, surgical
510(k) Number K202463
Device Name Disposable Surgical Mask
Unisources Group LLC
7460 NW 52nd Street
miami,  FL  33166
Applicant Contact henry shen
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
ludlum,  FL  33155
Correspondent Contact rafael aguila
Regulation Number878.4040
Classification Product Code
Date Received08/27/2020
Decision Date 09/18/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No