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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K223643
Device Name Verifine® Ease Lancing Device, Verifine® Lancing Device
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community
Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Zearou Yang
Correspondent
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community
Yuhang District
Hangzhou City,  CN 311121
Correspondent Contact Zearou Yang
Regulation Number878.4850
Classification Product Code
QRL  
Date Received12/06/2022
Decision Date 02/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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