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Bios S.R.L.
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BIOSYAG MEDICAL SYSTEM is an FDA 510(k)-cleared medical device (K080374) manufactured by Bios S.R.L.. 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 May 14, 2008. Regulation: 8.