FDA 510(k) Application Details - K152802

Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered

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510(K) Number K152802
Device Name Endoscopic Grasping/Cutting Instrument, Non-Powered
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 OCZ
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Date Received 09/28/2015
Decision Date 01/21/2016
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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