The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Conmed Goldvac Integrated Smoke Evacuation Pencil.
| Device ID | K081634 |
| 510k Number | K081634 |
| Device Name: | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORPORATION 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Contact | Shawn Riedel |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-11 |
| Decision Date | 2008-06-25 |
| Summary: | summary |