Button Loop

Fastener, Fixation, Nondegradable, Soft Tissue

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 Button Loop.

Pre-market Notification Details

Device IDK202291
510k NumberK202291
Device Name:Button Loop
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
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 CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-12
Decision Date2021-01-08

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