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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 K222641
Device Name Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
Applicant
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Robert Zott
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Robert Zott
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received09/01/2022
Decision Date 11/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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