The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Endo.
Device ID | K180262 |
510k Number | K180262 |
Device Name: | SICAT Endo |
Classification | System, Image Processing, Radiological |
Applicant | SICAT GmbH & Co. KG Brunnenallee 6 Bonn, DE 53177 |
Contact | Manfred Breuer |
Correspondent | Frederik Kunze 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 | 2018-01-30 |
Decision Date | 2018-03-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D776ENDOV20 | K180262 | 000 |
D776ENDOV200 | K180262 | 000 |
D77666224630 | K180262 | 000 |
D776ENDOV20400 | K180262 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SICAT ENDO 79143705 4673498 Live/Registered |
SiCAT GmbH & Co. KG 2013-08-09 |
![]() SICAT ENDO 79142440 4669203 Live/Registered |
SiCAT GmbH & Co. KG 2013-08-09 |