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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 K221629
Device Name Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
60 Middletown Avenue
North Haven,  CT  06473
Applicant Contact Katherine Y. Choi
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Katherine Y. Choi
Regulation Number878.4740
Classification Product Code
Subsequent Product Code
Date Received06/06/2022
Decision Date 02/22/2023
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