| Device Classification Name |
Frame, Spectacle
|
| 510(k) Number |
K941414 |
| Device Name |
EYECOTECH CORP |
| Applicant |
| Eyecotech Corp. |
| 2729 S. Pepperdale Dr. |
|
Rowland Heights,
CA
91748
|
|
| Applicant Contact |
JENNIFER KUO |
| Correspondent |
| Eyecotech Corp. |
| 2729 S. Pepperdale Dr. |
|
Rowland Heights,
CA
91748
|
|
| Correspondent Contact |
JENNIFER KUO |
| Regulation Number | 886.5842 |
| Classification Product Code |
|
| Date Received | 03/23/1994 |
| Decision Date | 07/12/1994 |
| 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
|
|
|