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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K191827
Device Name Sunmed Disposable Angio-Closure Pads
Applicant
Sunny Medical Device (Shenzhen) Co., Ltd.
56 Lehigh Aisle
Irvine,  CA  92612
Applicant Contact James Qi Zhang
Correspondent
Sunny Medical Device (Shenzhen) Co., Ltd.
56 Lehigh Aisle
Irvine,  CA  92612
Correspondent Contact James Qi Zhang
Regulation Number870.4450
Classification Product Code
DXC  
Date Received07/08/2019
Decision Date 03/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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