CS 9300, CS 9300C


Device Classification Name

x-ray, tomography, computed, dental

510(k) Number K103659
Device Name CS 9300, CS 9300C
Applicant
TROPHY
4 rue f. pelloutier croissy
beaubourg
marne la vallee cedex 2, 

FR

77437

Applicant Contact marie-pierre labat-camy
Correspondent
TROPHY
4 rue f. pelloutier croissy
beaubourg
marne la vallee cedex 2, 

FR

77437

Correspodent Contact marie-pierre labat-camy
Regulation Number 892.1750
Classification Product Code
OAS  
Date Received 12/15/2010
Decision Date 08/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No