K942823 is an FDA 510(k) clearance for the MAHE INSTRUMENTS, a Electrosurgical Device (Class II — Special Controls, product code DWG), submitted by Mahe Intl., Inc. (Nashville, US). The FDA issued a Cleared decision on December 5, 1994, 174 days after receiving the submission on June 14, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K942823 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 14, 1994 |
| Decision Date | December 05, 1994 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | DWG — Electrosurgical Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |