The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Single Use Lee Electrode.
| Device ID | K913213 |
| 510k Number | K913213 |
| Device Name: | SINGLE USE LEE ELECTRODE |
| Classification | Electrocautery, Gynecologic (and 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 | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-19 |
| Decision Date | 1992-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405010255 | K913213 | 000 |
| 20653405010248 | K913213 | 000 |
| 20653405010262 | K913213 | 000 |