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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 K973962
Device Name BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
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 Received10/16/1997
Decision Date 02/19/1998
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
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