The following data is part of a premarket notification filed by Beacon Laboratories, Inc. with the FDA for Disposable Electrosurgery Ball Electrode.
| Device ID | K925708 |
| 510k Number | K925708 |
| Device Name: | DISPOSABLE ELECTROSURGERY BALL ELECTRODE |
| Classification | Electrosurgical Device |
| 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 | DWG |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1993-04-20 |