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FDA 510(k), K183053, Olympus Small Intestinal Capsule Endoscope System
FDA 510(k), K183053, Olympus Small Intestinal Capsule Endoscope System
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$149.00 USD
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510(K) Number: K183053
Device Name: Olympus Small Intestinal Capsule Endoscope System
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 11/02/2018
Decision Date: 03/05/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Olympus Small Intestinal Capsule Endoscope System
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 11/02/2018
Decision Date: 03/05/2019
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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