The following data is part of a premarket notification filed by Cogent Light Technologies, Inc. with the FDA for Solartec Source 270, Model # 90123.
Device ID | K983714 |
510k Number | K983714 |
Device Name: | SOLARTEC SOURCE 270, MODEL # 90123 |
Classification | Image, Illumination, Fiberoptic, For Endoscope |
Applicant | COGENT LIGHT TECHNOLOGIES, INC. 26145 TECHNOLOGY DR. Santa Clarita, CA 91355 -1137 |
Contact | Don Knaepple |
Correspondent | Don Knaepple COGENT LIGHT TECHNOLOGIES, INC. 26145 TECHNOLOGY DR. Santa Clarita, CA 91355 -1137 |
Product Code | FFS |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-21 |
Decision Date | 1998-12-23 |
Summary: | summary |