ENTERAL NUTRITION WARMER


Device Classification Name

warmer, thermal, infusion fluid

510(k) Number K122449
Device Name ENTERAL NUTRITION WARMER
Applicant
ACACIA, INC.
785 challenger st.
brea, 
CA 
92821

Applicant Contact fergie ferguson
Correspondent
ACACIA, INC.
785 challenger st.
brea, 
CA 
92821

Correspodent Contact fergie ferguson
Classification Product Code
LGZ  
Date Received 08/13/2012
Decision Date 06/13/2013
Decision

substantially equivalent

(SESE)

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No