
Encompass Group, LLC
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ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN is an FDA 510(k)-cleared medical device (K982058) manufactured by Encompass Group, 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 January 13, 1999. Regulation: 8.