LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER

LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER is an FDA 510(k)-cleared medical device (K974796) manufactured by Medispec, Ltd.. 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 March 11, 1998. Regulation: 8.