
Techstyles
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GOWN BACK, MODEL 13-403N; 13-404N; 13-405N is an FDA 510(k)-cleared medical device (K992436) manufactured by Techstyles. 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 19, 2000. Regulation: 8.