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 |