Surgical Face Mask

Mask, Surgical

Amphastar Nanjing Pharmaceuticals, Inc.

The following data is part of a premarket notification filed by Amphastar Nanjing Pharmaceuticals, Inc. with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK201545
510k NumberK201545
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Amphastar Nanjing Pharmaceuticals, Inc. No.5 Xinghe Road, Nanjing Economic And Technological Development Zone Nanjing,  CN 210038
ContactBob Bao
CorrespondentBob Bao
Amphastar Nanjing Pharmaceuticals, Inc. No.5 Xinghe Road, Nanjing Economic And Technological Development Zone Nanjing,  CN 210038
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-09
Decision Date2021-02-12

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