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Banta Healthcare
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100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN is an FDA 510(k)-cleared medical device (K003749) manufactured by Banta Healthcare. 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 February 22, 2001. Regulation: 8.