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 |