| 510(k) Number |
K828056 |
| Device Name |
MODEL 716 MICROMANIPULATOR |
| Applicant |
| Laser Industries , Ltd. |
| Science Based Industrial Park |
| Atidim Neve Sharett Pob 13135 |
|
Tel Aviv,
IL
61131
|
|
| Correspondent |
| Laser Industries , Ltd. |
| Science Based Industrial Park |
| Atidim Neve Sharett Pob 13135 |
|
Tel Aviv,
IL
61131
|
|
| Date Received | 12/06/1982 |
| Decision Date | 01/06/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|