The following data is part of a premarket notification filed by Sedecal S.a. with the FDA for Urs Lp Digital, Millennium, Radpro.
| Device ID | K042876 |
| 510k Number | K042876 |
| Device Name: | URS LP DIGITAL, MILLENNIUM, RADPRO |
| Classification | System, X-ray, Stationary |
| Applicant | SEDECAL S.A. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SEDECAL S.A. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-18 |
| Decision Date | 2004-11-18 |
| Summary: | summary |