The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Mf-450 Electrosurgical Unit 60-5500-001.
| Device ID | K896839 |
| 510k Number | K896839 |
| Device Name: | MF-450 ELECTROSURGICAL UNIT 60-5500-001 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABORATORIES, INC. 8089 S. LINCOLN ST. Littleton, CO 80122 |
| Contact | Jane Johnson |
| Correspondent | Jane Johnson ASPEN LABORATORIES, INC. 8089 S. LINCOLN ST. Littleton, CO 80122 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-05 |
| Decision Date | 1990-02-02 |