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FDA 510(k), K140284, GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
FDA 510(k), K140284, GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
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510(K) Number: K140284
Device Name: GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
Manufacturer: GIVEN IMAGING LTD.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 02/04/2014
Decision Date: 12/17/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
Manufacturer: GIVEN IMAGING LTD.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 02/04/2014
Decision Date: 12/17/2014
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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