K831192 is an FDA 510(k) clearance for the INFUSION CANNULA. This device is classified as a Cannula, Ophthalmic (Class I - General Controls, product code HMX).
Submitted by Medical Instrument Development Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983, 79 days after receiving the submission on April 12, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K831192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1983 |
| Decision Date | June 30, 1983 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HMX — Cannula, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |