K890365 is an FDA 510(k) clearance for the SEPTUM ELEVATOR. This device is classified as a Elevator, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEG).
Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on February 3, 1989, 11 days after receiving the submission on January 23, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K890365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1989 |
| Decision Date | February 03, 1989 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEG — Elevator, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |