The following data is part of a premarket notification filed by Slow Wave, Inc. with the FDA for Slow Wave Ds8.
| Device ID | K191320 |
| 510k Number | K191320 |
| Device Name: | Slow Wave DS8 |
| Classification | Device, Jaw Repositioning |
| Applicant | Slow Wave, Inc. 26100 Countryside Dr. Spicewood, TX 78669 |
| Contact | Wayne R. Wagner |
| Correspondent | Wayne R. Wagner Slow Wave, Inc. 26100 Countryside Dr. Spicewood, TX 78669 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-15 |
| Decision Date | 2020-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007686610 | K191320 | 000 |
| 00860007686603 | K191320 | 000 |