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FDA 510(k), K140841, TABLO CARTRIDGE
FDA 510(k), K140841, TABLO CARTRIDGE
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510(K) Number: K140841
Device Name: TABLO CARTRIDGE
Manufacturer: HOME DIALYSIS PLUS
Device Classification Name: set, tubing, blood, with and without anti-regurgitation valve
Regulation Number: 876.5820
Classification Product Code: FJK
Date Received: 04/02/2014
Decision Date: 09/11/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: TABLO CARTRIDGE
Manufacturer: HOME DIALYSIS PLUS
Device Classification Name: set, tubing, blood, with and without anti-regurgitation valve
Regulation Number: 876.5820
Classification Product Code: FJK
Date Received: 04/02/2014
Decision Date: 09/11/2014
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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