
Baxter Healthcare Corp
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STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE is an FDA 510(k)-cleared medical device (K924101) manufactured by Baxter Healthcare 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 April 10, 1994. Regulation: 8.