About This 510(k) Submission
K003445 is an FDA 510(k) clearance for the FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2, a Protector, Transducer, Dialysis (Class II — Special Controls, product code FIB), submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on December 1, 2000, 25 days after receiving the submission on November 6, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.