The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction.
| Device ID | K052104 |
| 510k Number | K052104 |
| Device Name: | ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORPORATION 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Contact | Pamela Vetter |
| Correspondent | Pamela Vetter CONMED CORPORATION 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-03 |
| Decision Date | 2005-10-21 |
| Summary: | summary |