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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 K761151
Device Name INFUSION PUMP
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
FRN  
Date Received11/29/1976
Decision Date 12/09/1976
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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