The following data is part of a premarket notification filed by Premier with the FDA for Electrosurgical Electrode.
| Device ID | K925116 |
| 510k Number | K925116 |
| Device Name: | ELECTROSURGICAL ELECTRODE |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | PREMIER 1710 ROMANO DR. P.O. BOX 111 Norristown, PA 19404 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER 1710 ROMANO DR. P.O. BOX 111 Norristown, PA 19404 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-09 |
| Decision Date | 1994-03-01 |