FDA 510(k), K042938, GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
FDA 510(k), K042938, GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
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$149.00 USD
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$149.00 USD
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510(K) Number: K042938
Device Name: GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
Manufacturer:
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 10/25/2004
Decision Date: 01/06/2005
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
Manufacturer:
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 10/25/2004
Decision Date: 01/06/2005
Regulation Medical Specialty: Gastroenterology/Urology