The following data is part of a premarket notification filed by Mpowrx Health And Wellness Products Inc. with the FDA for Mpowrx Snoring Solution.
| Device ID | K081965 |
| 510k Number | K081965 |
| Device Name: | MPOWRX SNORING SOLUTION |
| Classification | Device, Anti-snoring |
| Applicant | MPOWRX HEALTH AND WELLNESS PRODUCTS INC. 1705 S. CAPITAL OF TEXAS HWY. SUITE 500 Austin, TX 78746 |
| Contact | Jean Asquith |
| Correspondent | Jean Asquith MPOWRX HEALTH AND WELLNESS PRODUCTS INC. 1705 S. CAPITAL OF TEXAS HWY. SUITE 500 Austin, TX 78746 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-10 |
| Decision Date | 2008-10-27 |
| Summary: | summary |