The following data is part of a premarket notification filed by Designs For Vision, Inc. with the FDA for Designs For Vision Fiberoptic Light.
| Device ID | K032283 |
| 510k Number | K032283 |
| Device Name: | DESIGNS FOR VISION FIBEROPTIC LIGHT |
| Classification | Endoscope, Fiber Optic |
| Applicant | DESIGNS FOR VISION, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane DESIGNS FOR VISION, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | GDB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-24 |
| Decision Date | 2003-08-20 |
| Summary: | summary |