FDA Product Code
FDA Product Code PKA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.5900
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K173934 | Reza Band, Reflux Band | Somna Therapeutics, LLC | 2018-04-13 | Traditional | PDF ↗ |
| DEN130046 | REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE | Somna Therapeutics, LLC | 2015-03-06 | Direct | — |
Product code PKA · Class II · Ear, Nose, Throat. Data: openFDA.