510(k) K083542

FRESENIUS STERILE STAY SAFE CAP by Fresenius Medical Care North America — Product Code KDJ

K083542 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESENIUS STERILE STAY SAFE CAP". The FDA issued a decision of Substantially Equivalent on December 29, 2008. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.