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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 K182475
Device Name Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 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 Number878.4750
Classification Product Code
Subsequent Product Code
Date Received09/10/2018
Decision Date 03/14/2019
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