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FDA 510(k) Application Details - K172807
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K172807
Device Name
Catheter, Retention Type, Balloon
Applicant
Changzhou Rongxin Medicine Minimal Invasion Technology
No. 8, Jianerkang Road, Industrial Concentration Area,
Zhixi Town
Jintan City 213251 CN
Other 510(k) Applications for this Company
Contact
Ping Liu
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
09/18/2017
Decision Date
06/04/2018
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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