SICAT OPTIMOTION
Mouthguard, Prescription
SICAT GMBH & CO. KG
The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Optimotion.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D776105010 | K143655 | 000 |
Trademark Results [SICAT OPTIMOTION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SICAT OPTIMOTION 79156469 4857221 Live/Registered |
SiCAT GmbH & Co. KG 2014-03-21 |
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