The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Somnomed Bflex.
| Device ID | K073004 |
| 510k Number | K073004 |
| Device Name: | SOMNOMED BFLEX |
| Classification | Device, Anti-snoring |
| Applicant | SOMNOMED INC. 3537 TEASLEY LANE Denton, TX 76210 |
| Contact | Ashley Truitt |
| Correspondent | Ashley Truitt SOMNOMED INC. 3537 TEASLEY LANE Denton, TX 76210 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-24 |
| Decision Date | 2008-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851826007038 | K073004 | 000 |
| 00851826007014 | K073004 | 000 |
| 00851826007007 | K073004 | 000 |