Device Classification Name |
Lens, Spectacle, Non-Custom (Prescription)
|
510(k) Number |
K881225 |
Device Name |
OPHTHALMIC SPECTACLE LENS BLANKS |
Applicant |
BETA OPTICAL CO, INC. |
7041 SW 21 PLACE |
DAVIE,
FL
33317
|
|
Applicant Contact |
JAMES MAGALHAES |
Correspondent |
BETA OPTICAL CO, INC. |
7041 SW 21 PLACE |
DAVIE,
FL
33317
|
|
Correspondent Contact |
JAMES MAGALHAES |
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 03/22/1988 |
Decision Date | 04/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|