FDA 510(k) Application Details - K172762

Device Classification Name

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510(K) Number K172762
Device Name Single Use Hemoclip
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

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Classification Product Code PKL
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Date Received 09/13/2017
Decision Date 03/20/2018
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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