The following data is part of a premarket notification filed by Sovis Optique with the FDA for Sovis Optique's Endoscopic Cable.
| Device ID | K023633 |
| 510k Number | K023633 |
| Device Name: | SOVIS OPTIQUE'S ENDOSCOPIC CABLE |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | SOVIS OPTIQUE 700 THIRTEENTH ST. NW SUITE 1200 Washington, DC 20005 |
| Contact | Frances K Wu |
| Correspondent | Frances K Wu SOVIS OPTIQUE 700 THIRTEENTH ST. NW SUITE 1200 Washington, DC 20005 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-29 |
| Decision Date | 2002-12-31 |
| Summary: | summary |