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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K231491
Device Name TA™ Stapler and Loading Unit with DST Series™ Technology
Applicant
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Emily Jacobs
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Emily Jacobs
Regulation Number878.4740
Classification Product Code
GAG  
Subsequent Product Code
GDW  
Date Received05/23/2023
Decision Date 08/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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