Device Classification Name |
unit, x-ray, extraoral with timer
|
510(k) Number |
K040556 |
Device Name |
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY |
Applicant |
EASTMAN KODAK COMPANY |
343 STATE ST. |
ROCHESTER,
NY
14650
|
|
Applicant Contact |
DONALD ELLIS |
Correspondent |
EASTMAN KODAK COMPANY |
343 STATE ST. |
ROCHESTER,
NY
14650
|
|
Correspondent Contact |
DONALD ELLIS |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 03/02/2004 |
Decision Date | 04/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|