The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase Connect.
| Device ID | K113599 |
| 510k Number | K113599 |
| Device Name: | SURGICASE CONNECT |
| Classification | System, Image Processing, Radiological |
| Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Alexandra Razzhivina |
| Correspondent | Alexandra Razzhivina MATERIALISE N.V. TECHNOLOGIELAAN 15 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 | 2011-12-05 |
| Decision Date | 2012-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314SURGICASECONNECTIP0 | K113599 | 000 |