EMBOZENE MICROSPHERES


Device Classification Name

device, vascular, for promoting embolization

510(k) Number K073417
Device Name EMBOZENE MICROSPHERES
Applicant
CELONOVA BIOSCIENCES, INC.
49 spring st.
newman, 
GA 
30263

Applicant Contact thomas a gordy
Correspondent
CELONOVA BIOSCIENCES, INC.
49 spring st.
newman, 
GA 
30263

Correspodent Contact thomas a gordy
Regulation Number 870.3300
Classification Product Code
KRD  
Date Received 12/04/2007
Decision Date 12/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No