
Smith & Nephew, Inc.
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RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device is an FDA 510(k)-cleared medical device (K143133) 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 July 22, 2015. Regulation: 8.