Device Classification Name |
lens, spectacle, non-custom (prescription)
|
510(k) Number |
K850905 |
Device Name |
CR-39 TYPE RESIN |
Applicant |
ORPLEX CORP. |
1882 REYNOLDS AVE. |
IRVINE,
CA
92714
|
|
Applicant Contact |
HENRY ORLOSKY |
Correspondent |
ORPLEX CORP. |
1882 REYNOLDS AVE. |
IRVINE,
CA
92714
|
|
Correspondent Contact |
HENRY ORLOSKY |
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 03/05/1985 |
Decision Date | 03/20/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|