Device Classification Name |
Lens, Spectacle, Non-Custom (Prescription)
|
510(k) Number |
K882308 |
Device Name |
CR-39 PLASTIC LENSES FOR EYEGLASSES |
Applicant |
AUTOMATED LENS SYSTEM |
6376 S.W. 10 TERRACE |
MIAMI,
FL
33144
|
|
Applicant Contact |
MICHAEL WALACH |
Correspondent |
AUTOMATED LENS SYSTEM |
6376 S.W. 10 TERRACE |
MIAMI,
FL
33144
|
|
Correspondent Contact |
MICHAEL WALACH |
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 06/03/1988 |
Decision Date | 07/22/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|