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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 K890736
Device Name TFV-2300 INFUSION PUMP
Applicant
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Applicant Contact PAUL D HASFORTH
Correspondent
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Correspondent Contact PAUL D HASFORTH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/13/1989
Decision Date 07/09/1990
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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