The following data is part of a premarket notification filed by Sedecal S.a. with the FDA for Sedecal X-plus Lp Plus Digital Diagnostic X-ray Systems.
| Device ID | K090238 |
| 510k Number | K090238 |
| Device Name: | SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS |
| Classification | System, X-ray, Stationary |
| Applicant | SEDECAL S.A. 333 MILFORD ROAD Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SEDECAL S.A. 333 MILFORD ROAD 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 | 2009-02-02 |
| Decision Date | 2009-02-27 |
| Summary: | summary |