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FDA 510(k) Application Details - K150434
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K150434
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
Micro-Tech (Nanjing) CO., Ltd.
NO. 10 Gaoke Third Road
Nanjing 210032 CN
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Contact
Becky Li
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Regulation Number
876.1500
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Classification Product Code
FBK
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More FDA Info for this Product Code
Date Received
02/19/2015
Decision Date
06/02/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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