The following data is part of a premarket notification filed by Somnomed Inc with the FDA for Somnobrux Splints.
Device ID | K102909 |
510k Number | K102909 |
Device Name: | SOMNOBRUX SPLINTS |
Classification | Mouthguard, Prescription |
Applicant | SOMNOMED INC 7460 WARREN PARKWAY SUITE 190 Frisco, TX 75034 |
Contact | Bradley Southworth |
Correspondent | Bradley Southworth SOMNOMED INC 7460 WARREN PARKWAY SUITE 190 Frisco, TX 75034 |
Product Code | MQC |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-01 |
Decision Date | 2011-12-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851826007151 | K102909 | 000 |