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Pentapharm , Ltd.
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PEFAKIT APC-R FACTOR V LEIDEN is an FDA 510(k)-cleared medical device (K042762) manufactured by Pentapharm , Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2004. Regulation: 8.