Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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 Blood Lancet, Verifine Safety Lancet, Verifine Mini-safety Lancet.

Pre-market Notification Details

Device IDK221368
510k NumberK221368
Device Name:Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
ClassificationSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
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,  HK
Product CodeFMK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-12
Decision Date2022-06-09

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