YADU Surgical Gowns

Gown, Surgical

HeNan YADU Industrial Co., Ltd.

The following data is part of a premarket notification filed by Henan Yadu Industrial Co., Ltd. with the FDA for Yadu Surgical Gowns.

Pre-market Notification Details

Device IDK220092
510k NumberK220092
Device Name:YADU Surgical Gowns
ClassificationGown, Surgical
Applicant HeNan YADU Industrial Co., Ltd. No. 234, West Jianpu Road Changyuan,  CN 453400
ContactCharles Shen
CorrespondentCharles Shen
Manton Business And Technology Services 37 Winding Ridge Oakland,  NJ  07436
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-12
Decision Date2022-10-07

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