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FDA 510(k) Application Details - K202698
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K202698
Device Name
Catheter, Retention Type, Balloon
Applicant
Hangzhou Primecare Medical Co., Ltd.
Room 408-409, Zancheng Center West, Shangcheng District
Hangzhou 310008 CN
Other 510(k) Applications for this Company
Contact
Xueqing Yan
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
09/16/2020
Decision Date
12/15/2020
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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