Disposable Surgical Mask

Mask, Surgical

Unisources Group LLC

The following data is part of a premarket notification filed by Unisources Group Llc with the FDA for Disposable Surgical Mask.

Pre-market Notification Details

Device IDK202463
510k NumberK202463
Device Name:Disposable Surgical Mask
ClassificationMask, Surgical
Applicant Unisources Group LLC 7460 NW 52nd Street Miami,  FL  33166
ContactHenry Shen
CorrespondentRafael Aguila
Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 403 Ludlum,  FL  33155
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-27
Decision Date2020-09-18

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