510(k) K053169

RM3 RENAL PRESERVATION SYSTEM by Waters Instruments, Inc. — Product Code KDK

K053169 is an FDA 510(k) premarket notification submitted by Waters Instruments, Inc. for the device "RM3 RENAL PRESERVATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 17, 2006. The device falls under product code KDK (Container, Transport, Kidney), a Class II device regulated under 21 CFR 876.5880. Waters Instruments, Inc. has at least 10 other 510(k) clearances on record.