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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K842905
Device Name TRAVENOL MULTIDAY INFUSOR 2C1080
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/24/1984
Decision Date 11/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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