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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 K221005
Device Name EEA Circular 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 Choi
Regulation Number878.4750
Classification Product Code
Subsequent Product Code
Date Received04/05/2022
Decision Date 04/29/2022
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