KODAK 9000, KODAK 9000 3D


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K073435
Device Name KODAK 9000, KODAK 9000 3D
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 872.1800
Classification Product Code
MUH  
Date Received 12/06/2007
Decision Date 02/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No