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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K141998
Device Name SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
Applicant
Pinghu Sama Medical Packing Co., Ltd.
853 Dorchester Ln, Unit-B
New Milford,  NJ  07646
Applicant Contact CHARLES SHEN
Correspondent
Pinghu Sama Medical Packing Co., Ltd.
853 Dorchester Ln, Unit-B
New Milford,  NJ  07646
Correspondent Contact CHARLES SHEN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/23/2014
Decision Date 09/19/2014
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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