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Life-Tech Intl., Inc.
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PROLONG, MODELS PL50, PL100, PL150 is an FDA 510(k)-cleared medical device (K001129) manufactured by Life-Tech Intl., 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 July 5, 2000. Regulation: 8.