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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defoamer, Cardiopulmonary Bypass
510(k) Number K990514
Device Name MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
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 Number870.4230
Classification Product Code
DTP  
Subsequent Product Code
DTN  
Date Received02/18/1999
Decision Date 03/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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