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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 K180325
Device Name Single Use MultiClip Device
Applicant
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing,  CN
Applicant Contact Becky Li
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing,  CN
Correspondent Contact Becky Li
Regulation Number876.4400
Classification Product Code
PKL  
Date Received02/05/2018
Decision Date 06/01/2018
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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