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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
510(k) Number K781383
Device Name INTERFACE CARDIOTOMY BLOOD FILTER
Applicant
Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4270
Classification Product Code
JOD  
Date Received08/11/1978
Decision Date 09/27/1978
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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