| Device Classification Name |
Perimeter, Automatic, Ac-Powered
|
| 510(k) Number |
K902878 |
| Device Name |
MT-336 AUTOMATIC PERIMETER |
| Applicant |
| Marco Technologies |
| R.D. #3 Box 237 |
| Welisewitz Rd. |
|
Ringoes,
NJ
08551
|
|
| Applicant Contact |
RANDOLPH L COOKE |
| Correspondent |
| Marco Technologies |
| R.D. #3 Box 237 |
| Welisewitz Rd. |
|
Ringoes,
NJ
08551
|
|
| Correspondent Contact |
RANDOLPH L COOKE |
| Regulation Number | 886.1605 |
| Classification Product Code |
|
| Date Received | 07/02/1990 |
| Decision Date | 09/18/1990 |
| 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
|
|
|