FDA 510(k), K150221, EPX-4440HD and EPX-4400HD with FICE

FDA 510(k), K150221, EPX-4440HD and EPX-4400HD with FICE

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510(K) Number: K150221
Device Name: EPX-4440HD and EPX-4400HD with FICE
Manufacturer: MARY MOORE
Device Classification Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation Number: FET
Classification Product Code: 01/30/2015
Date Received: 10/01/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

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