The following data is part of a premarket notification filed by Designs For Vision, Inc. with the FDA for Daylite Xenon Light Sources.
| Device ID | K013880 |
| 510k Number | K013880 |
| Device Name: | DAYLITE XENON LIGHT SOURCES |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | DESIGNS FOR VISION, INC. 760 KOEHLER AVE. Ronkonkoma, NY 11779 |
| Contact | Amy Grumet-avallone |
| Correspondent | Donald J Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2001-12-07 |
| Summary: | summary |