Device Classification Name |
implant, eye sphere
|
510(k) Number |
K003338 |
Device Name |
BIO-EYE II ORBITAL IMPLANT |
Applicant |
INTEGRATED ORBITAL IMPLANTS, INC. |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
INTEGRATED ORBITAL IMPLANTS, INC. |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 886.3320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/25/2000 |
Decision Date | 02/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|