Disposable Surgical Gowns

Gown, Isolation, Surgical

Chongqing Litai Fashion Group Limited Company

The following data is part of a premarket notification filed by Chongqing Litai Fashion Group Limited Company with the FDA for Disposable Surgical Gowns.

Pre-market Notification Details

Device IDK210785
510k NumberK210785
Device Name:Disposable Surgical Gowns
ClassificationGown, Isolation, Surgical
Applicant Chongqing Litai Fashion Group Limited Company Building D7-1, Chongqing China Textile & Garment City Project, Maliu Yanjiang Development Zone, Chongqing,  CN
ContactDavid Ni
CorrespondentEva Li
Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai,  CN 200122
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-16
Decision Date2021-11-13

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