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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 K855067
Device Name SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100
Applicant
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact VERA BUFFALOE
Correspondent
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact VERA BUFFALOE
Regulation Number870.4270
Classification Product Code
JOD  
Date Received12/18/1985
Decision Date 02/26/1986
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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