FDA 510(k) Application Details - K191900

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

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510(K) Number K191900
Device Name Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant Zhejiang Chuangxiang Medical Technology Co., LTD.
301B, No.22, XinYan Road
Hanzhou 311100 CN
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Contact Lucius Long
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Regulation Number 876.1500

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Classification Product Code OCZ
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Date Received 07/16/2019
Decision Date 03/27/2020
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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