510(k) DEN130046
- Device
- REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
- Applicant
- Somna Therapeutics, LLC
- 510(k) number
- DEN130046
- Product code
- PKA
- Decision
- Unknown (DENG)
- Decision date
- 2015-03-06
- Date received
- 2013-11-14
- Regulation
- 874.5900
- Classification name
- External Upper Esophageal Sphincter (Ues) Compression Device
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- James S. Miller
- Address
- W175 N11081 Stonewood Dr. Germantown WI US 53022 53022
FDA Registration Numbers#
- 3039167637
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PKA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173934 | Reza Band, Reflux Band | Somna Therapeutics, LLC | 2018-04-13 |