| Device Classification Name |
Photocoagulator And Accessories
|
| 510(k) Number |
K924090 |
| Device Name |
THE ENDO OPTIKS MICROPROBE |
| Applicant |
| Endo Optics, Inc. |
| C/O Knopf Associates, Inc. |
| 28 Marigold Lane |
|
Marlboro,
NJ
07746
|
|
| Applicant Contact |
MARTIN S KNOPF |
| Correspondent |
| Endo Optics, Inc. |
| C/O Knopf Associates, Inc. |
| 28 Marigold Lane |
|
Marlboro,
NJ
07746
|
|
| Correspondent Contact |
MARTIN S KNOPF |
| Regulation Number | 886.4690 |
| Classification Product Code |
|
| Date Received | 08/13/1992 |
| Decision Date | 02/01/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|