Device Classification Name |
implant, eye sphere
|
510(k) Number |
K992294 |
Device Name |
BIOCERAMIC ORBITAL IMPLANT |
Applicant |
FCI OPHTHALMICS, INC. |
P.O. BOX 465 |
76 PROSPECT ST. |
MARSHFIELD HILLS,
MA
02051
|
|
Applicant Contact |
ANNE BOHSACK |
Correspondent |
FCI OPHTHALMICS, INC. |
P.O. BOX 465 |
76 PROSPECT ST. |
MARSHFIELD HILLS,
MA
02051
|
|
Correspondent Contact |
ANNE BOHSACK |
Regulation Number | 886.3320
|
Classification Product Code |
|
Date Received | 07/07/1999 |
Decision Date | 04/19/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|