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FDA 510(k) Application Details - K172758
Device Classification Name
Snare, Flexible
More FDA Info for this Device
510(K) Number
K172758
Device Name
Snare, Flexible
Applicant
Zhejiang Chuangxiang Medical Technology Co., LTD.
301B, No.22, XinYan Road
Hanzhou 311100 CN
Other 510(k) Applications for this Company
Contact
Lucius Long
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
FDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2017
Decision Date
03/07/2018
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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