KODAK 9000C EXTRAORAL IMAGING SYSTEM


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K080889
Device Name KODAK 9000C EXTRAORAL IMAGING SYSTEM
Applicant
TROPHY
4 rue f. pelloutier
croissy-beaubourg, 

FR

77435

Applicant Contact marie-pierre labat-camy
Correspondent
TROPHY
4 rue f. pelloutier
croissy-beaubourg, 

FR

77435

Correspodent Contact marie-pierre labat-camy
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 03/31/2008
Decision Date 04/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No