The following data is part of a premarket notification filed by Cogent Light Technologies, Inc. with the FDA for Cogent Light Illuminator 10010 Xenon Light Source.
Device ID | K933405 |
510k Number | K933405 |
Device Name: | COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE |
Classification | Light Source, Endoscope, Xenon Arc |
Applicant | COGENT LIGHT TECHNOLOGIES, INC. 650 SOUTH SAN VINCENT BLVD. Los Angeles, CA 90048 -4620 |
Contact | Robert J Bard |
Correspondent | Robert J Bard COGENT LIGHT TECHNOLOGIES, INC. 650 SOUTH SAN VINCENT BLVD. Los Angeles, CA 90048 -4620 |
Product Code | GCT |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-12 |
Decision Date | 1994-02-18 |