Submission Details
| 510(k) Number | K813483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 1981 |
| Decision Date | January 22, 1982 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K813483 is an FDA 510(k) clearance for the OMS ANTERIOR CHAMBER INFUSION NEEDLE, submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982, 52 days after receiving the submission on December 1, 1981. This device falls under the Ophthalmic review panel.
| 510(k) Number | K813483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 1981 |
| Decision Date | January 22, 1982 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | — |
| Device Class | — |