Device Classification Name |
Implant, Eye Sphere
|
510(k) Number |
K082850 |
Device Name |
EYE SPHERES |
Applicant |
PRODUCT AND EDUCATIONAL SERVICES LLC |
3805 OLD EASTON ROAD |
DOLYESTOWN,
PA
18902
|
|
Applicant Contact |
EDWARD GRIFFITH |
Correspondent |
PRODUCT AND EDUCATIONAL SERVICES LLC |
3805 OLD EASTON ROAD |
DOLYESTOWN,
PA
18902
|
|
Correspondent Contact |
EDWARD GRIFFITH |
Regulation Number | 886.3320
|
Classification Product Code |
|
Date Received | 09/29/2008 |
Decision Date | 02/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|