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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 K130867
Device Name ENFLOW IV FLUID WARMER INSULATED STRAP
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 Received03/28/2013
Decision Date 06/14/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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