510(k) K173934
- Device
- Reza Band, Reflux Band
- Applicant
- Somna Therapeutics, L.L.C.
- 510(k) number
- K173934
- Product code
- PKA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-13
- Date received
- 2017-12-26
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- James S. Miller
- Address
- W175 N11081 Stonewood Dr. Germantown WI US 53022 53022
FDA Registration Numbers#
- 3039167637
Source Documents#
Other 510(k) Records For Product Code PKA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN130046 | REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE | Somna Therapeutics, LLC | 2015-03-06 |
Legacy Summary#
summary
FDA Review#
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