Device Classification Name |
implant, eye sphere
|
510(k) Number |
K053298 |
Device Name |
ALPHASPHERE ORBITAL IMPLANT |
Applicant |
HYDRON PTY LIMITED |
733 BOLSANA DRIVE |
LAGUNA BEACH,
CA
92651
|
|
Applicant Contact |
JUDY F GORDON |
Correspondent |
HYDRON PTY LIMITED |
733 BOLSANA DRIVE |
LAGUNA BEACH,
CA
92651
|
|
Correspondent Contact |
JUDY F GORDON |
Regulation Number | 886.3320
|
Classification Product Code |
|
Date Received | 11/25/2005 |
Decision Date | 05/09/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|