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FDA 510(k) Application Details - K172762
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PKL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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