High Strength Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

Yunyi (Beijing) Medical Device Co., LTD

The following data is part of a premarket notification filed by Yunyi (beijing) Medical Device Co., Ltd with the FDA for High Strength Suture.

Pre-market Notification Details

Device IDK192637
510k NumberK192637
Device Name:High Strength Suture
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant Yunyi (Beijing) Medical Device Co., LTD Floor 1-4, Building 4, No. 9 Tianfu Street Biomedical Base, Daxing District Beijing,  CN 102600
ContactXiaowei Liu
CorrespondentDiana Hong
Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-24
Decision Date2020-03-02

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