Surgical Gown, Reinforced Surgical Gown

Gown, Surgical

Wuhan Zonsen Medical Products Co.,Ltd

The following data is part of a premarket notification filed by Wuhan Zonsen Medical Products Co.,ltd with the FDA for Surgical Gown, Reinforced Surgical Gown.

Pre-market Notification Details

Device IDK212861
510k NumberK212861
Device Name:Surgical Gown, Reinforced Surgical Gown
ClassificationGown, Surgical
Applicant Wuhan Zonsen Medical Products Co.,Ltd No.8 Jinchao Road Zhucheng Street Xinzhou District Wuhan,  CN 431400
ContactCynthia Ye
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14 Th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-09-08
Decision Date2021-12-15

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