| 510(k) Number |
K837465 |
| Device Name |
ALCYON ROTATIONAL COBALT THERAPY |
| Applicant |
| Cgr Medical Corp. |
| 10150 Old Columbia Rd. |
|
Columbia,
MD
21046
|
|
| Correspondent |
| Cgr Medical Corp. |
| 10150 Old Columbia Rd. |
|
Columbia,
MD
21046
|
|
| Date Received | 05/03/1983 |
| Decision Date | 06/28/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|