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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 K911000
Device Name PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
Applicant
DATASCOPE CORP.
3 FIR CT.
P.O. BOX 3100
OAKLAND,  NJ  07436
Applicant Contact BILL CORRIGAN
Correspondent
DATASCOPE CORP.
3 FIR CT.
P.O. BOX 3100
OAKLAND,  NJ  07436
Correspondent Contact BILL CORRIGAN
Regulation Number870.3535
Classification Product Code
DSP  
Date Received03/08/1991
Decision Date 08/25/1993
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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