PERF-GEN PULSATILE PERFUSION SOLUTION

PERF-GEN PULSATILE PERFUSION SOLUTION is an FDA 510(k)-cleared medical device (K121736) manufactured by Waters Medical Systems, LLC. 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 August 15, 2013. Regulation: 8.