M1 Surgical Face Mask

Mask, Surgical

CHISON Medical Technologies Co., Ltd.

The following data is part of a premarket notification filed by Chison Medical Technologies Co., Ltd. with the FDA for M1 Surgical Face Mask.

Pre-market Notification Details

Device IDK202457
510k NumberK202457
Device Name:M1 Surgical Face Mask
ClassificationMask, Surgical
Applicant CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park, Xinwu District Wuxi,  CN 214142
ContactQifei Liu
CorrespondentQifei Liu
CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park, Xinwu District Wuxi,  CN 214142
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-27
Decision Date2021-04-29

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