MEDCOMP REPAIR KIT, MODEL ASPCRPK

MEDCOMP REPAIR KIT, MODEL ASPCRPK is an FDA 510(k)-cleared medical device (K022570) manufactured by Medcomp. 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 October 30, 2002. Regulation: 8.