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Sebia
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CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM is an FDA 510(k)-cleared medical device (K112550) manufactured by Sebia. 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 24, 2012. Regulation: 8.