Plus Medical Chemotherapy Gown

Gown, Surgical

Foshan Nanhai Plus Medical CO LTD

The following data is part of a premarket notification filed by Foshan Nanhai Plus Medical Co Ltd with the FDA for Plus Medical Chemotherapy Gown.

Pre-market Notification Details

Device IDK211036
510k NumberK211036
Device Name:Plus Medical Chemotherapy Gown
ClassificationGown, Surgical
Applicant Foshan Nanhai Plus Medical CO LTD Shatou Jiujiang Town, Nanhai District Foshan,  CN 528200
ContactEric Li
CorrespondentOlivia Meng
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou,  CN 510006
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-07
Decision Date2022-05-04


Device IdentifiersubmissionNumberSupplement
16973062321479 K211036 000
16973062321462 K211036 000
16973062321455 K211036 000
16973062321448 K211036 000

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