K-numberK162710
Device nameSingle Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
ApplicantTgs Medical Co., Ltd.
Product codeGDW
Device classClass II
Decision dateFeb 9, 2017
DecisionSubstantially Equivalent
Regulation878.4750
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