| Device Classification Name |
Processor, Radiographic-Film, Automatic, Dental
|
| 510(k) Number |
K900156 |
| Device Name |
AP201 DENTAL X-RAY FILM PROCESSOR |
| Applicant |
| Allied Photo Products Co., Inc. |
| 5440-A Oakbrook Pkwy. |
|
Norcross,
GA
30093
|
|
| Applicant Contact |
GISELLE R FREYRE |
| Correspondent |
| Allied Photo Products Co., Inc. |
| 5440-A Oakbrook Pkwy. |
|
Norcross,
GA
30093
|
|
| Correspondent Contact |
GISELLE R FREYRE |
| Regulation Number | 892.1900 |
| Classification Product Code |
|
| Date Received | 01/12/1990 |
| Decision Date | 05/14/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|