The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Excalibur Electrosurgical Unit.
| Device ID | K924960 |
| 510k Number | K924960 |
| Device Name: | EXCALIBUR ELECTROSURGICAL UNIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
| Contact | Jane Johnson |
| Correspondent | Jane Johnson ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-04-16 |