The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Galileos Implant, V 1.0.
| Device ID | K061472 |
| 510k Number | K061472 |
| Device Name: | GALILEOS IMPLANT, V 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | SICAT GMBH & CO. KG BRUNNENALLEE 6 Bonn, DE D-53177 |
| Contact | Markus Parker |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-30 |
| Decision Date | 2006-06-09 |
| Summary: | summary |