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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(k) Number K111405
Device Name BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
Applicant
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
NO. 8-1, LONGQUAN ROAD
CANGQIAN TOWN, YUHANG DISTRICT
HANGZHOU, ZHEJIANG,  CN 311121
Applicant Contact ALLYSON ZHOU
Correspondent
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
NO. 8-1, LONGQUAN ROAD
CANGQIAN TOWN, YUHANG DISTRICT
HANGZHOU, ZHEJIANG,  CN 311121
Correspondent Contact ALLYSON ZHOU
Regulation Number876.5130
Classification Product Code
GBM  
Date Received05/19/2011
Decision Date 02/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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