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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K060537
Device Name EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
Applicant
ENGINIVITY LLC
8 GRAY LODGE ROAD
KITTERY,  ME  03904
Applicant Contact PENELOPE GRECO
Correspondent
ENGINIVITY LLC
8 GRAY LODGE ROAD
KITTERY,  ME  03904
Correspondent Contact PENELOPE GRECO
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received02/28/2006
Decision Date 06/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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