K905060 is an FDA 510(k) clearance for the ELECTRODE EXTENDER. This device is classified as a Electrode, Electrosurgical (Class II - Special Controls, product code JOS).
Submitted by Megadyne Medical Products, Inc. (Murray, US). The FDA issued a Cleared decision on April 12, 1991, 155 days after receiving the submission on November 8, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K905060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1990 |
| Decision Date | April 12, 1991 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JOS — Electrode, Electrosurgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |