Surgical Gowns

Gown, Surgical

Xiantao Dingcheng Non-Woven Product Co., Ltd

The following data is part of a premarket notification filed by Xiantao Dingcheng Non-woven Product Co., Ltd with the FDA for Surgical Gowns.

Pre-market Notification Details

Device IDK212718
510k NumberK212718
Device Name:Surgical Gowns
ClassificationGown, Surgical
Applicant Xiantao Dingcheng Non-Woven Product Co., Ltd Liukou Industrial Park Xiantao,  CN 433099
ContactCheng Qin
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-27
Decision Date2022-01-12

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