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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K150434
Device Name Injection Needle
Applicant
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing,  CN 210032
Applicant Contact Becky Li
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing,  CN 210032
Correspondent Contact Becky Li
Regulation Number876.1500
Classification Product Code
FBK  
Date Received02/19/2015
Decision Date 06/02/2015
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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