Medical Surgical Gowns

Gown, 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 Gowns.

Pre-market Notification Details

Device IDK202844
510k NumberK202844
Device Name:Medical Surgical Gowns
ClassificationGown, 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 CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-25
Decision Date2021-01-06

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