The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Conmed Aer Defense Smoke Evacuator.
| Device ID | K091139 |
| 510k Number | K091139 |
| Device Name: | CONMED AER DEFENSE SMOKE EVACUATOR |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | CONMED CORPORATION 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Contact | Demaris Velez |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-05-05 |
| Summary: | summary |