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FDA 510(k), K051520, GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
FDA 510(k), K051520, GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
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510(K) Number: K051520
Device Name: GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
Manufacturer: THOMAS B DOWELL
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 06/08/2005
Date Received: 12/09/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
Manufacturer: THOMAS B DOWELL
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 06/08/2005
Date Received: 12/09/2005
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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