
Smith & Nephew Equipment Group
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SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 is an FDA 510(k)-cleared medical device (K904965) manufactured by Smith & Nephew Equipment Group. 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 15, 1991. Regulation: 8.