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FDA 510(k) Application Details - K192468
Device Classification Name
Catheter, Urethral
More FDA Info for this Device
510(K) Number
K192468
Device Name
Catheter, Urethral
Applicant
Hangzhou Bever Medical Devices Co., Ltd.
Building 2, No. 1-1, Houmuqiao, Yongle Village,
Cangqian St., Yuhang Dist.
Hangzhou 311121 CN
Other 510(k) Applications for this Company
Contact
Allyson Zhou
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
GBM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2019
Decision Date
11/27/2019
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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