The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Somnodent Herbst; Classic, Flex.
Device ID | K130558 |
510k Number | K130558 |
Device Name: | SOMNODENT HERBST; CLASSIC, FLEX |
Classification | Device, Anti-snoring |
Applicant | SOMNOMED INC. 7460 Warren Pkwy Ste 190 Frisco, TX 75034 |
Contact | Kathryn A Jayne |
Correspondent | Kathryn A Jayne SOMNOMED INC. 7460 Warren Pkwy Ste 190 Frisco, TX 75034 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-04 |
Decision Date | 2013-05-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851826007168 | K130558 | 000 |
00851826007137 | K130558 | 000 |
00851826007120 | K130558 | 000 |
00851826007106 | K130558 | 000 |
00851826007076 | K130558 | 000 |
00851826007069 | K130558 | 000 |