The following data is part of a premarket notification filed by Materialise N.v. with the FDA for 3matic.
| Device ID | K060950 |
| 510k Number | K060950 |
| Device Name: | 3MATIC |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E3143MATICMEDICAL0 | K060950 | 000 |
| E31433MATICMEDICAL0 | K060950 | 000 |
| 05404028000700 | K060950 | 000 |