Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile

Gown, Surgical

Excellent Medical Technology Group Co., Ltd.

The following data is part of a premarket notification filed by Excellent Medical Technology Group Co., Ltd. with the FDA for Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-sterile.

Pre-market Notification Details

Device IDK220665
510k NumberK220665
Device Name:Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
ClassificationGown, Surgical
Applicant Excellent Medical Technology Group Co., Ltd. Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road Suzhou,  CN 215131
ContactKenney Song
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-07
Decision Date2022-06-03

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