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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 K212748
Device Name Disposable Dual Action Tissue Clip
Applicant
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech
Industrial Developement Zone
Nanjing,  CN 210032
Applicant Contact Cecilia Sun
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech
Industrial Developement Zone
Nanjing,  CN 210032
Correspondent Contact Cecilia Sun
Regulation Number876.4400
Classification Product Code
PKL  
Date Received08/30/2021
Decision Date 01/20/2022
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
Predetermined Change
Control Plan Authorized		 No
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