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 Number | 876.5130
|
Classification Product Code |
|
Date Received | 05/19/2011 |
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
|
|
|