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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 K853814
Device Name MP0400 ADULT, PERISTALIC INFUSION PUMP
Applicant
MEDEX, INC.
3637 LACON RD.
HILLARD,  OH  43026
Applicant Contact MESSINGER
Correspondent
MEDEX, INC.
3637 LACON RD.
HILLARD,  OH  43026
Correspondent Contact MESSINGER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/12/1985
Decision Date 01/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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