The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec 300w Xenon Light Source.
| Device ID | K070376 |
| 510k Number | K070376 |
| Device Name: | CONMED LINVATEC 300W XENON LIGHT SOURCE |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-08 |
| Decision Date | 2007-08-20 |
| Summary: | summary |