| Device Classification Name |
System, Applicator, Radionuclide, Manual
|
| 510(k) Number |
K890341 |
| Device Name |
MICK 200-TP AND MICK TP NEEDLE |
| Applicant |
| Mick Radio-Nuclear Instruments, Inc. |
| P.O. Box 99 |
|
Bronx,
NY
10465
|
|
| Applicant Contact |
FELIX W MICK |
| Correspondent |
| Mick Radio-Nuclear Instruments, Inc. |
| P.O. Box 99 |
|
Bronx,
NY
10465
|
|
| Correspondent Contact |
FELIX W MICK |
| Regulation Number | 892.5650 |
| Classification Product Code |
|
| Date Received | 01/23/1989 |
| Decision Date | 03/14/1989 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|