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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 K041281
Device Name DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
Applicant
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -3206
Applicant Contact JOANN TAYLOR
Correspondent
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -3206
Correspondent Contact JOANN TAYLOR
Regulation Number870.3535
Classification Product Code
DSP  
Date Received05/13/2004
Decision Date 06/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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