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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K202681
Device Name Promisemed Covered Safety Pen Needle
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community,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 Number880.5570
Classification Product Code
FMI  
Date Received09/15/2020
Decision Date 12/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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