| 510(k) Number |
K860928 |
| Device Name |
EYEMETER |
| Applicant |
| Indivisual Corporation, Inc. |
| Counsel For Indivisual Corp. |
| 10900 Wilshire Blvd. |
|
Los Angeles,
CA
90024
|
|
| Applicant Contact |
ROBERT B HUBBEL |
| Correspondent |
| Indivisual Corporation, Inc. |
| Counsel For Indivisual Corp. |
| 10900 Wilshire Blvd. |
|
Los Angeles,
CA
90024
|
|
| Correspondent Contact |
ROBERT B HUBBEL |
| Date Received | 03/11/1986 |
| Decision Date | 04/04/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|