The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Implant V2.0.
| Device ID | K192348 |
| 510k Number | K192348 |
| Device Name: | SICAT Implant V2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | SICAT GmbH & Co. KG Brunnenallee 6 Bonn, DE 53177 |
| Contact | Manfred Breuer |
| Correspondent | Manfred Breuer SICAT GmbH & Co. KG Brunnenallee 6 Bonn, DE 53177 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-29 |
| Decision Date | 2019-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D776IMPLANTV200 | K192348 | 000 |
| D776IMPLANTV20400 | K192348 | 000 |