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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 K161463
Device Name SureClip(TM) Repositionable Hemostasis Clip
Applicant
Micro-Tech (Nanjing) CO., Ltd.
no. 10 gaoke third road
nanjing,  CN 210032
Applicant Contact becky li
Correspondent
Micro-Tech (Nanjing) CO., Ltd.
no. 10 gaoke third road
nanjing,  CN 210032
Correspondent Contact becky li
Regulation Number876.4400
Classification Product Code
PKL  
Date Received05/26/2016
Decision Date 01/06/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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