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Mercator Healthcare , Ltd.
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MERCATOR HEALTHCARE MALE LATEX CONDOM is an FDA 510(k)-cleared medical device (K031369) manufactured by Mercator Healthcare , Ltd.. 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 October 30, 2003. Regulation: 8.

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