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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 K070225
Device Name SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
Applicant
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact ROBERT T KUNG
Correspondent
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact ROBERT T KUNG
Regulation Number870.3535
Classification Product Code
DSP  
Date Received01/24/2007
Decision Date 12/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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