The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Simplant Dr. James.
| Device ID | K053592 |
| 510k Number | K053592 |
| Device Name: | SIMPLANT DR. JAMES |
| Classification | System, Image Processing, Radiological |
| Applicant | MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Contact | Carl Van Lierde |
| Correspondent | Carl Van Lierde MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-23 |
| Decision Date | 2006-02-08 |
| Summary: | summary |