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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 K112902
Device Name ENFLOW IV FLUID WARMER
Applicant
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Applicant Contact STACIE GEFFNER-ATIYA
Correspondent
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Correspondent Contact STACIE GEFFNER-ATIYA
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received10/04/2011
Decision Date 03/14/2012
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
Predetermined Change
Control Plan Authorized		 No
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