The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Dragon X Spsl4hc, Dragon X Spsl8hc.
| Device ID | K173299 |
| 510k Number | K173299 |
| Device Name: | DRAGON X SPSL4HC, DRAGON X SPSL8HC |
| Classification | System, X-ray, Mobile |
| Applicant | Sedecal SA Pelaya, 9 Pol, Pol. Ind. "Rio De Janeiro" Algete, ES 28110 |
| Contact | Maluisa Gomez De Aguero |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct 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 | 2017-10-17 |
| Decision Date | 2018-01-26 |
| Summary: | summary |