
Blue Ocean Medical Product, LLC
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UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT is an FDA 510(k)-cleared medical device (K133333) manufactured by Blue Ocean Medical Product, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 30, 2014. Regulation: 8.