Plus Medical Cover 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 Cover Gown.

Pre-market Notification Details

Device IDK213177
510k NumberK213177
Device Name:Plus Medical Cover Gown
ClassificationGown, Surgical
Applicant Foshan Nanhai Plus Medical CO LTD Shatou Jiujiang Town, Nanhai District, Foshan, Foshan,  CN 528200
ContactEric Li
CorrespondentOlivia Meng
Guangzhou Osmunda Medical Device Technical Services 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 Received2021-09-28
Decision Date2022-05-11


Device IdentifiersubmissionNumberSupplement
16973062321431 K213177 000
30197344039597 K213177 000
16973062321363 K213177 000
16973062321370 K213177 000
16973062321387 K213177 000
16973062321394 K213177 000
16973062321400 K213177 000
16973062321417 K213177 000
16973062321424 K213177 000
30197344039580 K213177 000

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