The following data is part of a premarket notification filed by Cogent Light Technologies, Inc. with the FDA for Micro Link Endoscopic Fiber Cable, Model B1-90159.
Device ID | K001698 |
510k Number | K001698 |
Device Name: | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 |
Classification | Image, Illumination, Fiberoptic, For Endoscope |
Applicant | COGENT LIGHT TECHNOLOGIES, INC. 26145 TECHNOLOGY DR. Santa Clarita, CA 91355 -1137 |
Contact | Ed Currie |
Correspondent | Ed Currie COGENT LIGHT TECHNOLOGIES, INC. 26145 TECHNOLOGY DR. Santa Clarita, CA 91355 -1137 |
Product Code | FFS |
Subsequent Product Code | FST |
Subsequent Product Code | HBI |
Subsequent Product Code | KOD |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-02 |
Decision Date | 2000-07-17 |