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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 K122449
Device Name ENTERAL NUTRITION WARMER
Original Applicant
ACACIA, INC.
785 challenger st.
brea,  CA  92821
Original Contact fergie ferguson
Classification Product Code
LGZ  
Date Received08/13/2012
Decision Date 06/13/2013
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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