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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 K122405
Device Name AIR-BAND RADIAL COMPRESSION DEVICE
Original Applicant
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 law dr.
fairfield,  NJ  07004 -0011
Original Contact carla s cerqueira
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/07/2012
Decision Date 11/09/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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