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 |