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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 K193009
Device Name Promisemed Heel Blood Lancet
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
No. 12, Longtan Road, Cangqian Street
Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Zearou Yang
Correspondent
Vee Care (Asia) Limited
17th Chung Pont Commercial Building, 300 Hennessy Road
Hong Kong,  CN 0000
Correspondent Contact Wei Shan Hsu
Regulation Number878.4850
Classification Product Code
FMK  
Date Received10/28/2019
Decision Date 12/03/2019
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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