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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 K902277
Device Name BARD EXTRACORPOREAL CIRCULATION CANNULAE
Applicant
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Applicant Contact CHRISTINE MORGIDA
Correspondent
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Correspondent Contact CHRISTINE MORGIDA
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/21/1990
Decision Date 08/14/1990
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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