The following data is part of a premarket notification filed by Tomed Dr. Toussaint Gmbh with the FDA for Somnoguard Sp Soft.
| Device ID | K121761 |
| 510k Number | K121761 |
| Device Name: | SOMNOGUARD SP SOFT |
| Classification | Device, Anti-snoring |
| Applicant | TOMED DR. TOUSSAINT GMBH 854 US ROUTE 3 Holderness, NH 03245 |
| Contact | Scott Whitcomb |
| Correspondent | Scott Whitcomb TOMED DR. TOUSSAINT GMBH 854 US ROUTE 3 Holderness, NH 03245 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2012-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260383460310 | K121761 | 000 |
| 04260383460013 | K121761 | 000 |