510(k) K122449

ENTERAL NUTRITION WARMER by Acacia, Inc. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2013
Date Received
August 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type