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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 K121775
Device Name ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
Applicant
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY
20 campus rd
totowa,  NJ  07512
Applicant Contact stacie geffner-atiya
Correspondent
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY
20 campus rd
totowa,  NJ  07512
Correspondent Contact stacie geffner-atiya
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received06/18/2012
Decision Date 11/28/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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