FRESENIUS STERILE STAY SAFE CAP

FRESENIUS STERILE STAY SAFE CAP is an FDA 510(k)-cleared medical device (K083542) manufactured by Fresenius Medical Care North America. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 2008. Regulation: 8.