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FDA 510(k), K173363, Cycler Drain Bag Set
FDA 510(k), K173363, Cycler Drain Bag Set
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$149.00 USD
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$149.00 USD
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510(K) Number: K173363
Device Name: Cycler Drain Bag Set
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Device Classification Name: set, administration, for peritoneal dialysis, disposable
Regulation Number: 876.5630
Classification Product Code: KDJ
Date Received: 10/26/2017
Decision Date: 01/24/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Cycler Drain Bag Set
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Device Classification Name: set, administration, for peritoneal dialysis, disposable
Regulation Number: 876.5630
Classification Product Code: KDJ
Date Received: 10/26/2017
Decision Date: 01/24/2018
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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