| 510(k) Number |
K841430 |
| Device Name |
LASERSPEC |
| Applicant |
| Clement Clarke, Inc. |
| 6947 Americana Pkwy. |
|
Reynoldsburg ,
OH
43068 -
|
|
| Applicant Contact |
THOMAS E LEHMAN |
| Correspondent |
| Clement Clarke, Inc. |
| 6947 Americana Pkwy. |
|
Reynoldsburg ,
OH
43068 -
|
|
| Correspondent Contact |
THOMAS E LEHMAN |
| Date Received | 04/06/1984 |
| Decision Date | 12/13/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|