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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, implantable
510(k) Number K151163
Device Name Signia Loading Unit, Tri-Staple 2.0 Cartridge
Covidien LLC
60 Middletown Avenue
North Haven,  CT  06473
Applicant Contact Frank Gianelli
Covidien LLC
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Frank Gianelli
Regulation Number878.4750
Classification Product Code
Date Received05/01/2015
Decision Date 05/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No