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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K231721
Device Name Disposable Hot Biopsy Forceps
Applicant
Beijing Zksk Technology Co., Ltd.
Bldg. 9, 6 & #6 Yuan Hengye N. 7th St., Yongle
Economic Development Zone, Tongzho
Beijing,  CN 101105
Applicant Contact Ma Li
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.1801,#161,East Lu Jiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number876.4300
Classification Product Code
KGE  
Date Received06/13/2023
Decision Date 12/14/2023
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
Predetermined Change
Control Plan Authorized		 No
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