Medical Surgical Mask

Mask, Surgical

Beijing Biosis Healing Biological Technology Co., Ltd

The following data is part of a premarket notification filed by Beijing Biosis Healing Biological Technology Co., Ltd with the FDA for Medical Surgical Mask.

Pre-market Notification Details

Device IDK202029
510k NumberK202029
Device Name:Medical Surgical Mask
ClassificationMask, Surgical
Applicant Beijing Biosis Healing Biological Technology Co., Ltd No.6 Plant West, Valley No.1 Bio-medicine Industry Park, Daxing District Beijing,  CN 102600
ContactTing Jiang
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O.Box 120-119 Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-22
Decision Date2020-12-16

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