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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 K013326
Device Name MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
Applicant
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Applicant Contact JOANN WOLF
Correspondent
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Correspondent Contact JOANN WOLF
Regulation Number870.3535
Classification Product Code
DSP  
Date Received10/05/2001
Decision Date 11/02/2001
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
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