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FDA 510(k) Application Details - K202134
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K202134
Device Name
Catheter, Retention Type, Balloon
Applicant
Well Lead Medical Co., LTD.
C-4# Jinhu Industrial Estate, Hualong, Panyu
Guangzhou 511434 CN
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Contact
Jenny Zhu
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2020
Decision Date
04/08/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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