Device Classification Name |
lens, spectacle, non-custom (prescription)
|
510(k) Number |
K861162 |
Device Name |
LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) |
Applicant |
EFOP |
B P 193 |
13268 MARSEILLE CEDEX 8 |
FRANCE,
FR
|
|
Applicant Contact |
CARREL. |
Correspondent |
EFOP |
B P 193 |
13268 MARSEILLE CEDEX 8 |
FRANCE,
FR
|
|
Correspondent Contact |
CARREL. |
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 03/28/1986 |
Decision Date | 06/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|