The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Pantino Pro Positiner.
| Device ID | K102521 |
| 510k Number | K102521 |
| Device Name: | PANTINO PRO POSITINER |
| Classification | Device, Anti-snoring |
| Applicant | SOMNOMED INC. 3537 TEASLEY LANE Denton, TX 76210 |
| Contact | Bradley Southworth |
| Correspondent | Bradley Southworth 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 | 2010-09-02 |
| Decision Date | 2011-03-28 |
| Summary: | summary |