
Medigroup
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PC-205 TENCKHOFF CATHETER ROD OBTURATOR is an FDA 510(k)-cleared medical device (K823296) manufactured by Medigroup. 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 January 25, 1983. Regulation: 8.