K842983 is an FDA 510(k) clearance for the AMPCO OPTHALMIC TRAY. This device is classified as a Sponge, Ophthalmic (Class II - Special Controls, product code HOZ).
Submitted by Associated Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on May 22, 1985, 296 days after receiving the submission on July 30, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4790.
| 510(k) Number | K842983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1984 |
| Decision Date | May 22, 1985 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOZ — Sponge, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4790 |