Promisemed Sharps Container

Container, Sharps

Promisemed Hangzhou Meditech Co., Ltd.

The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Promisemed Sharps Container.

Pre-market Notification Details

Device IDK211890
510k NumberK211890
Device Name:Promisemed Sharps Container
ClassificationContainer, Sharps
Applicant Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community,Yuhang District Hangzhou City,  CN 311121
ContactZearou Yang
CorrespondentWei Shan Hsu
Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong,  CN
Product CodeMMK  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2021-11-17

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