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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K923231
Device Name CARDIO-PAK BASIC PUMP PACK
Applicant
Cardio-Med-Associates, Inc.
1602 4th Ave. N.
Billings,  MT  59101
Applicant Contact JEROME E DERNBACH
Correspondent
Cardio-Med-Associates, Inc.
1602 4th Ave. N.
Billings,  MT  59101
Correspondent Contact JEROME E DERNBACH
Regulation Number870.4390
Classification Product Code
DWE  
Subsequent Product Code
DTM  
Date Received07/01/1992
Decision Date 07/09/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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