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 |