Promisemed Covered Safety 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 Promisemed Covered Safety Pen Needle.

Pre-market Notification Details

Device IDK202681
510k NumberK202681
Device Name:Promisemed Covered Safety 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 0000
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-15
Decision Date2020-12-31

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