Nordiwell Medical Face Mask

Mask, Surgical

Changzhou Combat Protective Equipment Co., Ltd.

The following data is part of a premarket notification filed by Changzhou Combat Protective Equipment Co., Ltd. with the FDA for Nordiwell Medical Face Mask.

Pre-market Notification Details

Device IDK202615
510k NumberK202615
Device Name:Nordiwell Medical Face Mask
ClassificationMask, Surgical
Applicant Changzhou Combat Protective Equipment Co., Ltd. QingSiTang Village, Henglin Town, Wujin District Changzhou,  CN 213101
ContactYanmei Song
CorrespondentYanmei Song
Changzhou Combat Protective Equipment Co., Ltd. QingSiTang Village, Henglin Town, Wujin District Changzhou,  CN 213101
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-09
Decision Date2020-12-31

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