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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K760823
Device Name TMO OXYGENATOR RESERVOIR PUMP SET
Applicant
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4400
Classification Product Code
DTN  
Date Received10/13/1976
Decision Date 11/12/1976
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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