AXXENT VAGINAL APPLICATOR


Device Classification Name

system, therapeutic, x-ray

510(k) Number K072616
Device Name AXXENT VAGINAL APPLICATOR
Applicant
XOFT, INC.
49000 milmont drive
fremont, 
CA 
94538 -7301

Applicant Contact eric hashemian
Correspondent
XOFT, INC.
49000 milmont drive
fremont, 
CA 
94538 -7301

Correspodent Contact eric hashemian
Regulation Number 892.5900
Classification Product Code
JAD  
Date Received 09/17/2007
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No