FDA 510(k) Applications for Medical Device Product Code "PKA"

FDA 510(k) Number Applicant Device Name Decision Date
K173934 Somna Therapeutics, L.L.C. Reza Band, Reflux Band 04/13/2018
DEN130046 SOMNA THERAPEUTICS, LLC REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE 03/06/2015


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