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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 K913847
Device Name SYSTEM 90 AND SYSTEM 90T
Applicant
DATASCOPE CORP.
14 PHILIPS PKWY.
MONTVALE,  NJ  07645
Applicant Contact ARTHUR FRIEDMAN
Correspondent
DATASCOPE CORP.
14 PHILIPS PKWY.
MONTVALE,  NJ  07645
Correspondent Contact ARTHUR FRIEDMAN
Regulation Number870.3535
Classification Product Code
DSP  
Date Received08/27/1991
Decision Date 03/11/1992
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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