
Smith & Nephew, Inc.
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PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K112127) manufactured by Smith & Nephew, Inc.. 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 May 15, 2012. Regulation: 8.