The following data is part of a premarket notification filed by Genesis Medical, Inc. with the FDA for Electrosurgical Electrode Family.
| Device ID | K992045 |
| 510k Number | K992045 |
| Device Name: | ELECTROSURGICAL ELECTRODE FAMILY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GENESIS MEDICAL, INC. 524 WEDDEL DRIVE, SUITE 4 Sunnyvale, CA 94089 |
| Contact | Thomas Wehman |
| Correspondent | Thomas Wehman GENESIS MEDICAL, INC. 524 WEDDEL DRIVE, SUITE 4 Sunnyvale, CA 94089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-17 |
| Decision Date | 2000-01-27 |