Surgical Face Mask

Mask, Surgical

Mexpo International Inc.

The following data is part of a premarket notification filed by Mexpo International Inc. with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK200847
510k NumberK200847
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Mexpo International Inc. 2828 Faber Street Union City,  CA  94587
ContactTim Thai
CorrespondentTim Thai
Mexpo International Inc. 2828 Faber Street Union City,  CA  94587
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-04-23

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