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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K930593
Device Name BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU
Applicant
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Applicant Contact CELIA BUSCEMI
Correspondent
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Correspondent Contact CELIA BUSCEMI
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/04/1993
Decision Date 05/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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