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FDA 510(k), K093362, 2008 HEMODIALYSIS SORBENT SYSTEM
FDA 510(k), K093362, 2008 HEMODIALYSIS SORBENT SYSTEM
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510(K) Number: K093362
Device Name: 2008 HEMODIALYSIS SORBENT SYSTEM
Manufacturer: DAVID J VANELLA
Device Classification Name: System, Dialysate Delivery, Sorbent Regenerated
Regulation Number: FKT
Classification Product Code: 10/28/2009
Date Received: 08/13/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: 2008 HEMODIALYSIS SORBENT SYSTEM
Manufacturer: DAVID J VANELLA
Device Classification Name: System, Dialysate Delivery, Sorbent Regenerated
Regulation Number: FKT
Classification Product Code: 10/28/2009
Date Received: 08/13/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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