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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 K002949
Device Name MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
Applicant
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Applicant Contact JOANNE WOLF
Correspondent
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Correspondent Contact JOANNE WOLF
Regulation Number870.3535
Classification Product Code
DSP  
Date Received09/21/2000
Decision Date 10/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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