Medical Device Manufacturer · US , Germantown , WI

Somna Therapeutics, LLC - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2015

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Somna Therapeutics, LLC Ear, Nose, Throat ✕

2 devices

1-2 of 2

Cleared Apr 13, 2018

Reza Band, Reflux Band

Ear, Nose, Throat · 108d

Not Cleared Mar 06, 2015

REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE

DEN130046 · PKA

Ear, Nose, Throat · 477d