The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Implant.
| Device ID | K090119 |
| 510k Number | K090119 |
| Device Name: | SICAT IMPLANT |
| 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 | 2009-01-21 |
| Decision Date | 2009-02-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SICAT IMPLANT 79255943 not registered Live/Pending |
SiCAT GmbH & Co. KG 2019-02-21 |