The following data is part of a premarket notification filed by Novasys Medical, Inc. with the FDA for Electrosurgical Electrode Family.
| Device ID | K001151 |
| 510k Number | K001151 |
| Device Name: | ELECTROSURGICAL ELECTRODE FAMILY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. Sunnyvale, CA 94086 |
| Contact | Thomas Wehman |
| Correspondent | Thomas Wehman NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-06-27 |