Device Classification Name |
system, x-ray, extraoral source, digital
|
510(k) Number |
K093478 |
Device Name |
KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS 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
|
|
Correspondent Contact |
MARIE-PIERRE LABAT-CAMY |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 11/09/2009 |
Decision Date | 04/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|