The following data is part of a premarket notification filed by Somnomed Ltd with the FDA for Somnomed Mas Rxa.
| Device ID | K050592 |
| 510k Number | K050592 |
| Device Name: | SOMNOMED MAS RXA |
| Classification | Device, Anti-snoring |
| Applicant | SOMNOMED LTD PO BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan SOMNOMED LTD PO BOX 560 Stillwater, MN 55082 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-08 |
| Decision Date | 2005-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851826007113 | K050592 | 000 |
| 00851826007021 | K050592 | 000 |