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Kolplast CI Ltda
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KOLPLUX SYSTEM is an FDA 510(k)-cleared medical device (K110766) manufactured by Kolplast CI Ltda. 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 September 14, 2011. Regulation: 8.

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