
Implemed, Inc.
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OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 is an FDA 510(k)-cleared medical device (K990509) manufactured by Implemed, Inc.. 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 17, 1999. Regulation: 8.