The following data is part of a premarket notification filed by Soredex Palodex Group Oy with the FDA for Cranex D.
| Device ID | K043307 |
| 510k Number | K043307 |
| Device Name: | CRANEX D |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | SOREDEX PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI 00430 |
| Contact | Kai Laner |
| Correspondent | Kai Laner SOREDEX PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI 00430 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-01 |
| Decision Date | 2004-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872404 | K043307 | 000 |
| 06430035872398 | K043307 | 000 |