RM3 RENAL PRESERVATION SYSTEM

RM3 RENAL PRESERVATION SYSTEM is an FDA 510(k)-cleared medical device (K053169) manufactured by Waters Instruments, 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 January 16, 2006. Regulation: 8.