Device Classification Name |
Marker, Ocular
|
510(k) Number |
K925606 |
Device Name |
OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS |
Applicant |
CHIRON VISION CORP. |
9342 JERONIMO RD. |
IRVINE,
CA
92618 -1903
|
|
Applicant Contact |
CAROL L PATTERSON |
Correspondent |
CHIRON VISION CORP. |
9342 JERONIMO RD. |
IRVINE,
CA
92618 -1903
|
|
Correspondent Contact |
CAROL L PATTERSON |
Regulation Number | 886.4570
|
Classification Product Code |
|
Date Received | 11/05/1992 |
Decision Date | 08/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|