The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Electrodes.
| Device ID | K944992 |
| 510k Number | K944992 |
| Device Name: | ELECTRODES |
| Classification | Electrode, Electrosurgical |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-12 |
| Decision Date | 1995-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854030639 | K944992 | 000 |
| 20845854030636 | K944992 | 000 |
| 00845854030632 | K944992 | 000 |