Device Classification Name |
Catheter, Straight
|
510(k) Number |
K212430 |
Device Name |
BONREE Nelaton Catheter |
Applicant |
Bonree Medical Co., Ltd |
No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang |
Zhongshan,
CN
528451
|
|
Applicant Contact |
He Hongbo |
Correspondent |
Bonree Medical Co., Ltd |
No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang |
Zhongshan,
CN
528451
|
|
Correspondent Contact |
He Hongbo |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/04/2021 |
Decision Date | 04/29/2022 |
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
|
|
|