CHABNER XRT GARMENTS


Device Classification Name

accelerator, linear, medical

510(k) Number K121284
Device Name CHABNER XRT GARMENTS
Applicant
BFFL CO. INC
600 new hampshire avenue nw
suite 500
washington, 
DC 
20037

Applicant Contact evan p phelps
Correspondent
BFFL CO. INC
600 new hampshire avenue nw
suite 500
washington, 
DC 
20037

Correspodent Contact evan p phelps
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/30/2012
Decision Date 06/14/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No