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FDA 510(k) Application Details - K111405
Device Classification Name
Catheter, Urethral
More FDA Info for this Device
510(K) Number
K111405
Device Name
Catheter, Urethral
Applicant
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
NO. 8-1, LONGQUAN ROAD
CANGQIAN TOWN, YUHANG DISTRICT
HANGZHOU, ZHEJIANG 311121 CN
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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
05/19/2011
Decision Date
02/13/2012
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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