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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K221371
Device Name Promisemed Heel Blood Lancet
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
# 1388 Cangxing St.
Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Zearou Yang
Correspondent
Vee Care (Asia) Limited
17th Chung Pont Commercial Bldg., 300 Hennessy Rd.
Hong Kong,  HK
Correspondent Contact Wei Shan Hsu
Regulation Number878.4850
Classification Product Code
FMK  
Date Received05/12/2022
Decision Date 06/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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