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 |