The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Mf 360b Electrosurgical Unit.
| Device ID | K823923 |
| 510k Number | K823923 |
| Device Name: | MF 360B ELECTROSURGICAL UNIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-28 |
| Decision Date | 1983-02-15 |