K791898 is an FDA 510(k) clearance for the OCUTOME MODEL 8000. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II - Special Controls, product code HKP).
Submitted by Cooper Medical Devices Corp. (Mchenry, US). The FDA issued a Cleared decision on October 30, 1979, 35 days after receiving the submission on September 25, 1979.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K791898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1979 |
| Decision Date | October 30, 1979 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKP — Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |