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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, Elastomeric
510(k) Number K081905
Device Name ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
Applicant
Westmed, Inc.
3957 BLUE PINE CIRCLE
HIGHLANDS RANCH,  CO  80126 -8077
Applicant Contact CHARLES M HART
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number880.5725
Classification Product Code
MEB  
Date Received07/03/2008
Decision Date 07/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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