Surgical Gown

Gown, Surgical

Wujiang Tutaike Textiles & Finishing Co., Ltd.

The following data is part of a premarket notification filed by Wujiang Tutaike Textiles & Finishing Co., Ltd. with the FDA for Surgical Gown.

Pre-market Notification Details

Device IDK211077
510k NumberK211077
Device Name:Surgical Gown
ClassificationGown, Surgical
Applicant Wujiang Tutaike Textiles & Finishing Co., Ltd. No.1599, South 3rd Ring Road, Shengze, Wujiang Suzhou,  CN 317605
ContactZhang Yanwen
CorrespondentEva Li
Microkn Business Consulting (Shanghai) Co., Ltd Room 1215, Block A, No 3699, Gonghexin Road, Jingan District Shanghai,  CN
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-12
Decision Date2021-10-07

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