The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Dragon Lw.
| Device ID | K121410 |
| 510k Number | K121410 |
| Device Name: | DRAGON LW |
| Classification | System, X-ray, Mobile |
| Applicant | SEDECAL SA 8870 RAVELLO ST Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SEDECAL SA 8870 RAVELLO ST 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 | 2012-05-11 |
| Decision Date | 2012-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436046001879 | K121410 | 000 |