K945861 is an FDA 510(k) clearance for the BERGEN 710 ESU, a Apparatus, Electrosurgical (Class II — Special Controls, product code HAM), submitted by Bergen Mfg. (New Port Richey, US). The FDA issued a Cleared decision on March 1, 1995, 90 days after receiving the submission on December 1, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K945861 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 1994 |
| Decision Date | March 01, 1995 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HAM — Apparatus, Electrosurgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |