Device Classification Name |
eye, artificial, non-custom
|
510(k) Number |
K946226 |
Device Name |
CUSTOM OCULAR PROSTHESIS |
Applicant |
FRANK TANAKA, OCULARIST, INC. |
3000 EAST FLETCHER AVE., |
SUITE 310 |
TAMPA,
FL
33613
|
|
Applicant Contact |
K F TANAKA |
Correspondent |
FRANK TANAKA, OCULARIST, INC. |
3000 EAST FLETCHER AVE., |
SUITE 310 |
TAMPA,
FL
33613
|
|
Correspondent Contact |
K F TANAKA |
Regulation Number | 886.3200
|
Classification Product Code |
|
Date Received | 12/22/1994 |
Decision Date | 03/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|