The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Galileos Implant, Version 1.7.
| Device ID | K093090 |
| 510k Number | K093090 |
| Device Name: | GALILEOS IMPLANT, VERSION 1.7 |
| Classification | System, Image Processing, Radiological |
| Applicant | SICAT GMBH & CO. KG BRUNNENALLEE 6 Bonn, DE D-53177 |
| Contact | Markus Pfister |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW 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 | 2009-10-01 |
| Decision Date | 2009-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D776GIV1920 | K093090 | 000 |