The following data is part of a premarket notification filed by Aspen Labs with the FDA for Single Use Lee Electrode.
| Device ID | K912046 |
| 510k Number | K912046 |
| Device Name: | SINGLE USE LEE ELECTRODE |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | ASPEN LABS P.O. BOX 3936 Englewood, CO 80155 |
| Contact | Jane Johnson |
| Correspondent | Jane Johnson ASPEN LABS P.O. BOX 3936 Englewood, CO 80155 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-08 |
| Decision Date | 1992-03-05 |