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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 K042432
Device Name PHARMGUARD TOOLBOX, MODEL G6000782
Applicant
Medex, Inc.
6250 Shier Rings Rd.
Dublin,  OH  40316
Applicant Contact BARBARA LAW
Correspondent
Medex, Inc.
6250 Shier Rings Rd.
Dublin,  OH  40316
Correspondent Contact BARBARA LAW
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/08/2004
Decision Date 01/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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