About This 510(k) Submission
K021732 is an FDA 510(k) clearance for the DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on November 4, 2002, 164 days after receiving the submission on May 24, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.