
Hale Sun Industries, Ltd.
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HALE SUN SURGICAL TOWEL OR O.R. TOWEL is an FDA 510(k)-cleared medical device (K905803) manufactured by Hale Sun Industries, Ltd.. 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 20, 1991. Regulation: 8.