Verifine Safety Type Insulin Pen Needle

Needle, Hypodermic, Single Lumen

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 Safety Type Insulin Pen Needle.

Pre-market Notification Details

Device IDK210065
510k NumberK210065
Device Name:Verifine Safety Type Insulin Pen Needle
ClassificationNeedle, Hypodermic, Single Lumen
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 CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-11
Decision Date2021-04-22

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