
Life-Tech, Inc.
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PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS is an FDA 510(k)-cleared medical device (K072050) manufactured by Life-Tech, 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 October 17, 2007. Regulation: 8.