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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, balloon, intra-aortic and control
510(k) Number K921638
Device Name SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
Applicant
DATASCOPE CORP.
580 WINTERS AVE.
P.O. BOX 5
PARAMUS,  NJ  07653
Applicant Contact MICHAEL BARILE
Correspondent
DATASCOPE CORP.
580 WINTERS AVE.
P.O. BOX 5
PARAMUS,  NJ  07653
Correspondent Contact MICHAEL BARILE
Regulation Number870.3535
Classification Product Code
DSP  
Date Received04/06/1992
Decision Date 02/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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