INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150

INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 is an FDA 510(k)-cleared medical device (K990663) manufactured by Medtech , 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 May 26, 1999. Regulation: 8.