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FDA 510(k) Application Details - K142563
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K142563
Device Name
Catheter, Straight
Applicant
WELL LEAD MEDICAL CO., LTD.
C-4#Jinhu Industrial Estate, Hualong, Panyu
Guangzhou 511434 CN
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Contact
Han Guang Yuan
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/11/2014
Decision Date
10/28/2014
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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