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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K864235
Device Name BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
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 Number870.4350
Classification Product Code
DTZ  
Date Received10/28/1986
Decision Date 01/02/1987
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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