POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER

POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER is an FDA 510(k)-cleared medical device (K862124) manufactured by Polymed Laboratories. 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 13, 1986. Regulation: 8.