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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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