| 510(k) Number |
K842459 |
| Device Name |
SITE GILLS 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
|
|
| Date Received | 06/22/1984 |
| Decision Date | 08/15/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|