MRNA APPLIANCE
Device, Anti-snoring
BIOMODELING SOLUTIONS, LLS
The following data is part of a premarket notification filed by Biomodeling Solutions, Lls with the FDA for Mrna Appliance.
Pre-market Notification Details
| Device ID | K130067 |
| 510k Number | K130067 |
| Device Name: | MRNA APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | BIOMODELING SOLUTIONS, LLS 15455 NW GREENBRIER PARKWAY Beaverton, OR 97006 |
| Contact | Colette Cozean, Ph.d. |
| Correspondent | Colette Cozean, Ph.d. BIOMODELING SOLUTIONS, LLS 15455 NW GREENBRIER PARKWAY Beaverton, OR 97006 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-10 |
| Decision Date | 2014-05-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810002220166 | K130067 | 000 |
| 00810002220234 | K130067 | 000 |
Trademark Results [MRNA APPLIANCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MRNA APPLIANCE 85813312 4387563 Live/Registered |
BioModeling Solutions, LLC 2012-12-31 |
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