The following data is part of a premarket notification filed by Somna Therapeutics, L.l.c. with the FDA for Reza Band, Reflux Band.
| Device ID | K173934 |
| 510k Number | K173934 |
| Device Name: | Reza Band, Reflux Band |
| Classification | External Upper Esophageal Sphincter (ues) Compression Device |
| Applicant | Somna Therapeutics, L.L.C. W175 N11081 StoneWood Dr. Germantown, WI 53022 |
| Contact | James S. Miller |
| Correspondent | James S. Miller Somna Therapeutics, L.L.C. W175 N11081 StoneWood Dr. Germantown, WI 53022 |
| Product Code | PKA |
| CFR Regulation Number | 874.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-04-13 |
| Summary: | summary |