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FDA 510(k) Application Details - K210660
Device Classification Name
Catheter, Biliary, Surgical
More FDA Info for this Device
510(K) Number
K210660
Device Name
Catheter, Biliary, Surgical
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
No.3 Ave.8, HEDA
Hangzhou 310018 CN
Other 510(k) Applications for this Company
Contact
Huibing Yang
Other 510(k) Applications for this Contact
Regulation Number
876.5010
More FDA Info for this Regulation Number
Classification Product Code
GCA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/2021
Decision Date
04/27/2021
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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