The following data is part of a premarket notification filed by Sedecal S.a. with the FDA for Sedecal.
| Device ID | K103522 |
| 510k Number | K103522 |
| Device Name: | SEDECAL |
| Classification | System, X-ray, Mobile |
| Applicant | SEDECAL S.A. 8870 RAVELLO Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. SEDECAL S.A. 8870 RAVELLO Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-01 |
| Decision Date | 2011-01-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SEDECAL 74630773 not registered Dead/Abandoned |
SEDECAL, S.A. 1995-02-06 |