K821286 is an FDA 510(k) clearance for the IRIS SCISSORS STRAIGHT 4 1/2. This device is classified as a Scissors, Ophthalmic (Class I - General Controls, product code HNF).
Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 24 days after receiving the submission on May 4, 1982.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K821286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNF — Scissors, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |