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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 K981660
Device Name Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
Applicant
C.R. Bard, Inc.
25 Computer Dr.
Haverhill,  MA  01832
Applicant Contact SANDRA PERREAND
Correspondent
C.R. Bard, Inc.
25 Computer Dr.
Haverhill,  MA  01832
Correspondent Contact SANDRA PERREAND
Regulation Number870.3535
Classification Product Code
DSP  
Date Received05/11/1998
Decision Date 10/16/1998
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
Recalls CDRH Recalls
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