
Therex Corp.
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1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL is an FDA 510(k)-cleared medical device (K950131) manufactured by Therex Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 1995. Regulation: 8.

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