Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K842458 |
Device Name |
SITE SIMCOE STYLE I/A HANDPIECE |
Applicant |
CHIRON VISION CORP. |
9342 JERONIMO RD. |
IRVINE,
CA
92618 -1903
|
|
Correspondent |
CHIRON VISION CORP. |
9342 JERONIMO RD. |
IRVINE,
CA
92618 -1903
|
|
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 06/22/1984 |
Decision Date | 08/15/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|