FDA 510(k), K110823, PRISMAFLEX

FDA 510(k), K110823, PRISMAFLEX

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510(K) Number: K110823
Device Name: PRISMAFLEX
Manufacturer: GAMBRO RENAL PRODUCTS, INC.
Device Classification Name: dialyzer, high permeability with or without sealed dialysate system
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 03/24/2011
Decision Date: 06/17/2011
Regulation Medical Specialty: Gastroenterology/Urology
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