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Swemed Lab International AB
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BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 is an FDA 510(k)-cleared medical device (K022643) manufactured by Swemed Lab International AB. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2002. Regulation: 8.

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