Device Classification Name |
Implant, Eye Sphere
|
510(k) Number |
K982562 |
Device Name |
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER |
Applicant |
INTEGRATED ORBITAL IMPLANTS, INC. |
12526 HIGH BLUFF DR. |
SUITE 300 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
JEANNE DUNHAM |
Correspondent |
INTEGRATED ORBITAL IMPLANTS, INC. |
12526 HIGH BLUFF DR. |
SUITE 300 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
JEANNE DUNHAM |
Regulation Number | 886.3320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/23/1998 |
Decision Date | 12/28/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|