| Device Classification Name |
Accessories, Solution, Ultrasonic Cleaners For Lenses
|
| 510(k) Number |
K904824 |
| Device Name |
EASY EYES TM CONTACT LENS CLEANING MACHINE |
| Applicant |
| Eaton Medical Corp. |
| 2288 Dunn Ave. |
|
Memphis,
TN
38114
|
|
| Applicant Contact |
ELLIS M WHITE |
| Correspondent |
| Eaton Medical Corp. |
| 2288 Dunn Ave. |
|
Memphis,
TN
38114
|
|
| Correspondent Contact |
ELLIS M WHITE |
| Regulation Number | 886.5928 |
| Classification Product Code |
|
| Date Received | 10/25/1990 |
| Decision Date | 07/05/1991 |
| 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
|
|
|