The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center International Bv with the FDA for Xenon Brightstar Illumination System, Model 1266.xiii.
| Device ID | K062895 |
| 510k Number | K062895 |
| Device Name: | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII |
| Classification | Endoilluminator |
| Applicant | DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV ONE LITTLE RIVER RD. Kingston, NH 03848 |
| Contact | F Carleton |
| Correspondent | F Carleton DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV ONE LITTLE RIVER RD. Kingston, NH 03848 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-27 |
| Decision Date | 2006-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717872009421 | K062895 | 000 |
| 08717872014074 | K062895 | 000 |
| 08717872014067 | K062895 | 000 |
| 08717872009582 | K062895 | 000 |
| 08717872009568 | K062895 | 000 |
| 08717872009513 | K062895 | 000 |
| 08717872009506 | K062895 | 000 |
| 08717872009476 | K062895 | 000 |
| 08717872009452 | K062895 | 000 |
| 08717872009445 | K062895 | 000 |
| 08717872009414 | K062895 | 000 |
| 08717872009407 | K062895 | 000 |
| 08717872009391 | K062895 | 000 |
| 08717872009384 | K062895 | 000 |
| 08717872009377 | K062895 | 000 |
| 08717872009360 | K062895 | 000 |
| 08717872001081 | K062895 | 000 |
| 08717872014081 | K062895 | 000 |
| 08717872016009 | K062895 | 000 |
| 08717872021942 | K062895 | 000 |
| 08717872019604 | K062895 | 000 |
| 08717872018577 | K062895 | 000 |
| 08717872018416 | K062895 | 000 |
| 08717872018287 | K062895 | 000 |
| 08717872018270 | K062895 | 000 |
| 08717872018201 | K062895 | 000 |
| 08717872018195 | K062895 | 000 |
| 08717872017433 | K062895 | 000 |
| 08717872017426 | K062895 | 000 |
| 08717872016931 | K062895 | 000 |
| 08717872016870 | K062895 | 000 |
| 08717872016597 | K062895 | 000 |
| 08717872016351 | K062895 | 000 |
| 08717872016344 | K062895 | 000 |
| 08717872016320 | K062895 | 000 |
| 18717872009527 | K062895 | 000 |