Verifine Mechanical Safety Insulin Syringe

Syringe, Piston

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 Verifine Mechanical Safety Insulin Syringe.

Pre-market Notification Details

Device IDK210712
510k NumberK210712
Device Name:Verifine Mechanical Safety Insulin Syringe
ClassificationSyringe, Piston
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 CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-10
Decision Date2021-09-08

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