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H.S Hospital Service S.P.A
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HS AMICA is an FDA 510(k)-cleared medical device (K083157) manufactured by H.S Hospital Service S.P.A. 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 September 28, 2009. Regulation: 8.