| Device Classification Name |
Accelerator, Linear, Medical
|
| 510(k) Number |
K894706 |
| Device Name |
HT-RES RTP SYSTEM |
| Applicant |
| Adac Laboratories |
| 540 Alder Dr. |
|
Milpitas,
CA
95035
|
|
| Applicant Contact |
LARRY HERNANDEZ |
| Correspondent |
| Adac Laboratories |
| 540 Alder Dr. |
|
Milpitas,
CA
95035
|
|
| Correspondent Contact |
LARRY HERNANDEZ |
| Regulation Number | 892.5050 |
| Classification Product Code |
|
| Date Received | 07/24/1989 |
| Decision Date | 10/11/1989 |
| 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
|
|
|