About This 510(k) Submission
K170150 is an FDA 510(k) clearance for the Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags, a Set, Perfusion, Kidney, Disposable (Class II — Special Controls, product code KDL), submitted by S.A.L.F. Spa (Cenate Sotto, IT). The FDA issued a Cleared decision on October 20, 2017, 276 days after receiving the submission on January 17, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.