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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 K872378
Device Name WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
Applicant
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Applicant Contact JOSEPH KICEINA
Correspondent
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Correspondent Contact JOSEPH KICEINA
Regulation Number870.4400
Classification Product Code
DTN  
Date Received06/19/1987
Decision Date 09/14/1987
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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