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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 K031636
Device Name CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
Applicant
Datascope Corp.
800 Macarthur Blvd.
Mahwah,  NJ  07430 -0619
Applicant Contact SUSAN MANDY
Correspondent
Datascope Corp.
800 Macarthur Blvd.
Mahwah,  NJ  07430 -0619
Correspondent Contact SUSAN MANDY
Regulation Number870.3535
Classification Product Code
DSP  
Date Received05/27/2003
Decision Date 08/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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