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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 K150227
Device Name Disposable Blood Pressure Cuff Guard
Applicant
Pinhu Sama Medical Packing Co., Ltd.
1 Qunfeng Rd., S. Of Lindai
Pinghu,  CN 214202
Applicant Contact MA JIANZHONG
Correspondent
Beijing Believe Tech.Service Co., Ltd.
1-202, Build 3, Beijing New World
#5 Chaogyang Rd., Chaogyang District
Beijing,  CN 100024
Correspondent Contact RAY WANG
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received02/02/2015
Decision Date 04/02/2015
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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