The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Linvatec 300w Xenon Light Source.
Device ID | K031994 |
510k Number | K031994 |
Device Name: | LINVATEC 300W XENON LIGHT SOURCE |
Classification | Light Source, Endoscope, Xenon Arc |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Laura D Krejci |
Correspondent | Laura D Krejci LINVATEC CORP. 11311 CONCEPT BLVD. 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 | 2003-06-27 |
Decision Date | 2003-08-21 |
Summary: | summary |