The following data is part of a premarket notification filed by Aspen Labs with the FDA for Hyfrecator 2000.
| Device ID | K970493 |
| 510k Number | K970493 |
| Device Name: | HYFRECATOR 2000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABS 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Contact | Charles M Hart |
| Correspondent | Charles M Hart ASPEN LABS 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 | 1997-02-10 |
| Decision Date | 1997-04-30 |