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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
Model MODEL 100, MODEL 200 AND 202, MODEL 120 AND 121
Device Name ENFLOW IV FLUID WARMER
Original Applicant
VITAL SIGNS, INC.
20 campus rd.
totowa,  NJ  07512
Original Contact stacie geffner-atiya
Classification Product Code
LGZ  
Date Received10/12/2011
Decision Date 03/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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