Device Classification Name |
Set, Lens, Trial, Ophthalmic
|
510(k) Number |
K945443 |
Device Name |
BOBES LENS SET |
Applicant |
BOBES S.A. |
CTRA. FUENTE DEL TORO, S/N |
28710 EL MOLAR |
MADRID,
ES
|
|
Applicant Contact |
FRANCISCO J BOBES NAVES |
Correspondent |
BOBES S.A. |
CTRA. FUENTE DEL TORO, S/N |
28710 EL MOLAR |
MADRID,
ES
|
|
Correspondent Contact |
FRANCISCO J BOBES NAVES |
Regulation Number | 886.1405
|
Classification Product Code |
|
Date Received | 11/07/1994 |
Decision Date | 07/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|