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Tyco Healthcare Group LP
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AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT is an FDA 510(k)-cleared medical device (K080898) manufactured by Tyco Healthcare Group LP. 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 4, 2008. Regulation: 8.