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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K930299
Device Name BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
Applicant
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Applicant Contact ARTHUR FRIEDMAN
Correspondent
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Correspondent Contact ARTHUR FRIEDMAN
Regulation Number870.4400
Classification Product Code
DTN  
Date Received01/21/1993
Decision Date 06/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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