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Med Textile, LLC
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BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 is an FDA 510(k)-cleared medical device (K032568) manufactured by Med Textile, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 2004. Regulation: 8.