The following data is part of a premarket notification filed by Conmedcorp with the FDA for Hyfrecator 2000 Reusable Hand-switching Accessory Handpiece/foot-switching Accessory Handpiece, Hyfrecator Plus Reusabl.
| Device ID | K001159 |
| 510k Number | K001159 |
| Device Name: | HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMEDCORP 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Contact | Charles M (mike) Hart |
| Correspondent | Charles M (mike) Hart CONMEDCORP 14603 E. FREMONT AVE. Englewood, 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 | 2000-04-10 |
| Decision Date | 2000-06-07 |