Device Classification Name |
Conformer, Ophthalmic
|
510(k) Number |
K970318 |
Device Name |
OCULAR CONFORMER |
Applicant |
SOUTHWEST ARTIFICIAL EYES, INC. |
4640 CENTERVIEW |
SAN ANTONIO,
TX
78228
|
|
Applicant Contact |
DANIEL M WENSKE |
Correspondent |
SOUTHWEST ARTIFICIAL EYES, INC. |
4640 CENTERVIEW |
SAN ANTONIO,
TX
78228
|
|
Correspondent Contact |
DANIEL M WENSKE |
Regulation Number | 886.3130
|
Classification Product Code |
|
Date Received | 01/28/1997 |
Decision Date | 07/07/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|