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FDA 510(k) Application Details - K151745
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K151745
Device Name
Catheter, Straight
Applicant
SHAOXING FUQING HEALTH PRODUCTS CO., LTD.
NO. 599 WUXIE ROAD,
SHAOXING HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE
SHAOXING 312000 CN
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Contact
DEAN WU
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZD
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More FDA Info for this Product Code
Date Received
06/29/2015
Decision Date
03/03/2016
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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