
Medtek Development Corp.
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POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS is an FDA 510(k)-cleared medical device (K925077) manufactured by Medtek Development Corp.. 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 15, 1993. Regulation: 8.