Surgical Isolation Gown

Gown, Isolation, Surgical

Yanbian Pacific Textile Co., LTD

The following data is part of a premarket notification filed by Yanbian Pacific Textile Co., Ltd with the FDA for Surgical Isolation Gown.

Pre-market Notification Details

Device IDK203415
510k NumberK203415
Device Name:Surgical Isolation Gown
ClassificationGown, Isolation, Surgical
Applicant Yanbian Pacific Textile Co., LTD Longjing Industry Concentration Area Longjing City,  CN 133400
ContactJuan Zhuang
CorrespondentRafi Wong
Pacific Fortune Management Inc. 2350 Mission College BLVD, STE 475 Santa Clara,  CA  95054
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-19
Decision Date2021-05-20

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