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Teleflex Medical
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POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE is an FDA 510(k)-cleared medical device (K042141) manufactured by Teleflex Medical. 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 September 27, 2004. Regulation: 8.