
Smith & Nephew United, Inc.
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INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) is an FDA 510(k)-cleared medical device (K901876) manufactured by Smith & Nephew United, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 27, 1990. Regulation: 8.