| 510(k) Number |
K837344 |
| Device Name |
BEAM BLOCK SHAPER |
| Applicant |
| Mick Radio-Nuclear Instruments, Inc. |
| 1470 Outlook Ave. |
| P.O. Box 99 |
|
Bronx,
NY
10465
|
|
| Correspondent |
| Mick Radio-Nuclear Instruments, Inc. |
| 1470 Outlook Ave. |
| P.O. Box 99 |
|
Bronx,
NY
10465
|
|
| Date Received | 03/21/1983 |
| Decision Date | 05/09/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|