Surgical Gown, Model: Surgical Gown-hp-3

Gown, Surgical

Weihai Dishang Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Weihai Dishang Medical Technology Co., Ltd with the FDA for Surgical Gown, Model: Surgical Gown-hp-3.

Pre-market Notification Details

Device IDK210355
510k NumberK210355
Device Name:Surgical Gown, Model: Surgical Gown-hp-3
ClassificationGown, Surgical
Applicant Weihai Dishang Medical Technology Co., Ltd Room 406-409, Block C, No.213 Torch Road, Torch High-tech Industrial Development Zone Weihai,  CN 264209
ContactRicky Xia
CorrespondentRicky Xia
Weihai Dishang Medical Technology Co., Ltd Room 406-409, Block C, No.213 Torch Road, Torch High-tech Industrial Development Zone Weihai,  CN 264209
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-12-16

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