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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 K202701
Device Name GIA Stapler with Tri-Staple Technology
Rooms 501, 502, 601, 602, No.3 building No.2388,
Chen Hang Road
Min Hang District, Shanghai,  CN 201114
Applicant Contact Leo Chen
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Katherine Y. Choi
Regulation Number878.4750
Classification Product Code
Date Received09/16/2020
Decision Date 12/07/2020
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