| 510(k) Number |
K852229 |
| Device Name |
STERILE EYE PACKS OR TRAYS |
| Applicant |
| Surgeon Surgical Instrumentation, Inc. |
| 1061 N. Shepard St. |
| Suite C |
|
Anaheim,
CA
92806
|
|
| Applicant Contact |
RUTH CROOK |
| Correspondent |
| Surgeon Surgical Instrumentation, Inc. |
| 1061 N. Shepard St. |
| Suite C |
|
Anaheim,
CA
92806
|
|
| Correspondent Contact |
RUTH CROOK |
| Date Received | 05/22/1985 |
| Decision Date | 06/07/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|