The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Optimotion.
Device ID | K143655 |
510k Number | K143655 |
Device Name: | SICAT OPTIMOTION |
Classification | Mouthguard, Prescription |
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 | MQC |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-23 |
Decision Date | 2015-10-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D776105010 | K143655 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SICAT OPTIMOTION 79156469 4857221 Live/Registered |
SiCAT GmbH & Co. KG 2014-03-21 |