
Tlelflex Medical, Inc.
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PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM is an FDA 510(k)-cleared medical device (K120953) manufactured by Tlelflex Medical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 2012. Regulation: 8.