The following data is part of a premarket notification filed by Products For Medicine with the FDA for X6000d Silent Sun Light Source.
| Device ID | K955510 |
| 510k Number | K955510 |
| Device Name: | X6000D SILENT SUN LIGHT SOURCE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | PRODUCTS FOR MEDICINE 3722 AVE. SAUSALITO Irvine, CA 92714 |
| Contact | Greg Holland |
| Correspondent | Greg Holland PRODUCTS FOR MEDICINE 3722 AVE. SAUSALITO Irvine, CA 92714 |
| Product Code | FST |
| Subsequent Product Code | FFS |
| Subsequent Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-04 |
| Decision Date | 1996-01-31 |