Medical Face Mask

Mask, Surgical

Haian Medigauze Co., Ltd

The following data is part of a premarket notification filed by Haian Medigauze Co., Ltd with the FDA for Medical Face Mask.

Pre-market Notification Details

Device IDK212471
510k NumberK212471
Device Name:Medical Face Mask
ClassificationMask, Surgical
Applicant Haian Medigauze Co., Ltd Jiaoxie Industry Park, Haian Nantong,  CN 226633
ContactWeihua Xu
CorrespondentWeihua Xu
Haian Medigauze Co., Ltd Jiaoxie Industry Park, Haian Nantong,  CN 226633
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-06
Decision Date2021-11-04

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