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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 K120364
Device Name UNIMED DISPOSABLE BLOOD PRESSURE CUFF
Original Applicant
UNIMED MEDICAL SUPPLIES INC.
no.37, yanshan road, shekou
shenzhen, guangdong,  CH 518067
Original Contact xinmei tan
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received02/06/2012
Decision Date 05/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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