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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K812510
Device Name TRAVENOL INFUSION CONTROLLER 2M8052
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 Number880.5725
Classification Product Code
LDR  
Date Received09/02/1981
Decision Date 09/16/1981
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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