FDA 510(k), K153466, PillCam COLON 2 Capsule Endoscopy System

FDA 510(k), K153466, PillCam COLON 2 Capsule Endoscopy System

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510(K) Number: K153466
Device Name: PillCam COLON 2 Capsule Endoscopy System
Manufacturer: GIVEN IMAGING LTD.
Device Classification Name: colon capsule imaging system
Regulation Number: 876.1330
Classification Product Code: PGD
Date Received: 12/01/2015
Decision Date: 01/14/2016
Regulation Medical Specialty: Gastroenterology/Urology

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