Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes

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 Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes.

Pre-market Notification Details

Device IDK211242
510k NumberK211242
Device Name:Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
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 Received2021-04-26
Decision Date2021-09-09

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