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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
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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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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