SICAT OPTISLEEP
Device, Anti-snoring
SICAT GMBH & CO. KG
The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Optisleep.
Pre-market Notification Details
| Device ID | K153291 |
| 510k Number | K153291 |
| Device Name: | SICAT OPTISLEEP |
| Classification | Device, Anti-snoring |
| 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 | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-13 |
| Decision Date | 2016-03-31 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D776104010 | K153291 | 000 |
| D776OSLEEPV11 | K153291 | 000 |
| D776OSLEEPV110 | K153291 | 000 |
Trademark Results [SICAT OPTISLEEP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SICAT OPTISLEEP 79156825 4857226 Live/Registered |
SiCAT GmbH & Co. KG 2014-09-26 |
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