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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 K831705
Device Name WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
Applicant
C.R. Bard, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
C.R. Bard, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received05/26/1983
Decision Date 07/18/1983
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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