The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Lightwave Integrated Electrode Ablator And Light Wave Integrated Electrode Suction Ablator.
| Device ID | K050923 |
| 510k Number | K050923 |
| Device Name: | LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR |
| Classification | Electrode, Electrosurgical |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Elizabeth Paul |
| Correspondent | Elizabeth Paul CONMED LINVATEC 11311 CONCEPT BOULEVARD 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 | 2005-04-13 |
| Decision Date | 2005-05-18 |
| Summary: | summary |