
Serral, S.A. DE C.V.
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SERRALGUT is an FDA 510(k)-cleared medical device (K020597) manufactured by Serral, S.A. DE C.V.. 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 August 13, 2002. Regulation: 8.