REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE— 510(k) DEN130046

Name: FDA 510(k) clearance DEN130046
Creator: U.S. Food and Drug Administration
Published: 2015-03-06

Unknown

Somna Therapeutics, LLC

FDA 510(k) clearance DEN130046 for REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE, Unknown on 2015-03-06. Applicant: Somna Therapeutics, LLC. Device class: 2.

Clearance details

Applicant: Somna Therapeutics, LLC
Product code: Code PKA
Device class: Class 2
Regulation: 21 CFR 874.5900
Advisory panel: Ear, Nose, Throat
Date received: 2013-11-14
Decision date: 2015-03-06
Decision: Unknown
Clearance type: Direct
Location: Germantown, WI, US

View on FDA.gov ↗

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