
Hyphen Biomed
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BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 is an FDA 510(k)-cleared medical device (K050367) manufactured by Hyphen Biomed. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2006. Regulation: 8.