Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K172807 |
Device Name |
Silicone Foley Catheter for single use |
Applicant |
Changzhou Rongxin Medicine Minimal Invasion Technology |
No. 8, Jianerkang Road, Industrial Concentration Area, |
Zhixi Town |
Jintan City,
CN
213251
|
|
Applicant Contact |
Ping Liu |
Correspondent |
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. |
8-9Th Floor, R&D Building, No. 26 Qinglan Street |
Panyu District |
Guangzhou,
CN
510006
|
|
Correspondent Contact |
Mike Gu |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/18/2017 |
Decision Date | 06/04/2018 |
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
|
|
|