The following data is part of a premarket notification filed by Beacon Laboratories, Inc. with the FDA for Disposable Hand-switching Esu Pencil.
| Device ID | K925619 |
| 510k Number | K925619 |
| Device Name: | DISPOSABLE HAND-SWITCHING ESU PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BEACON LABORATORIES, INC. 2150 WEST 6TH AVE., UNIT P Broomfield, CO 80020 |
| Contact | Richard P Fleenor |
| Correspondent | Richard P Fleenor BEACON LABORATORIES, INC. 2150 WEST 6TH AVE., UNIT P Broomfield, CO 80020 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-06 |
| Decision Date | 1992-12-24 |