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FDA 510(k), K180026, Bowel Management Device, Bowel Management Irrigation Set
FDA 510(k), K180026, Bowel Management Device, Bowel Management Irrigation Set
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$149.00 USD
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510(K) Number: K180026
Device Name: Bowel Management Device, Bowel Management Irrigation Set
Manufacturer: Applied Medical Technology, Inc.
Device Classification Name: tubes, gastrointestinal (and accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 01/03/2018
Decision Date: 06/01/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Bowel Management Device, Bowel Management Irrigation Set
Manufacturer: Applied Medical Technology, Inc.
Device Classification Name: tubes, gastrointestinal (and accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 01/03/2018
Decision Date: 06/01/2018
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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