ASEPT PERITONEAL DRAINAGE SYSTEM

ASEPT PERITONEAL DRAINAGE SYSTEM is an FDA 510(k)-cleared medical device (K093796) manufactured by Pfm Medical, Inc.. 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 February 25, 2010. Regulation: 8.