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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 K940178
Device Name PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
Applicant
DATASCOPE CORP.
3 FIR CT.
P.O. BOX 3100
OAKLAND,  NJ  07436
Applicant Contact JOHN PICCIANO
Correspondent
DATASCOPE CORP.
3 FIR CT.
P.O. BOX 3100
OAKLAND,  NJ  07436
Correspondent Contact JOHN PICCIANO
Regulation Number870.3535
Classification Product Code
DSP  
Date Received01/12/1994
Decision Date 08/09/1994
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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