AVANT GUARDIAN 101


Device Classification Name

injector, fluid, non-electrically powered

510(k) Number K024018
Device Name AVANT GUARDIAN 101
Original Applicant
AVANT MEDICAL CORPORATION
3914 kendall st.
san diego, 
CA 
92109

Original Contact john b slate
Regulation Number 880.5430
Classification Product Code
KZE  
Date Received 12/04/2002
Decision Date 01/17/2003
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