The following data is part of a premarket notification filed by Designs For Vision, Inc. with the FDA for Dvi Curing Light.
| Device ID | K043530 |
| 510k Number | K043530 |
| Device Name: | DVI CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| 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 | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-21 |
| Decision Date | 2005-01-25 |
| Summary: | summary |