FDA 510(k), K182188, Ion Endoluminal System ; Flexision Biopsy Needle

FDA 510(k), K182188, Ion Endoluminal System ; Flexision Biopsy Needle

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510(K) Number: K182188
Device Name: Ion Endoluminal System ; Flexision Biopsy Needle
Manufacturer: Sarah Rizk
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: 08/13/2018
Date Received: 02/14/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat

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