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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hemostatic metal clip for the gi tract
510(k) Number K213217
Device Name Disposable hemoclip
Applicant
Beijing ZKSK Technology Co.,Ltd
Building 9, 6 & No.6 Yuan Hengye North 7th Street,
Yongle Economic Development Zone, Tongzho
Beijing,  CN 101105
Applicant Contact Ma Li
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.1801,No.161,East Lujiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number876.4400
Classification Product Code
PKL  
Date Received09/29/2021
Decision Date 11/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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