Device Classification Name |
catheter, straight
|
510(k) Number |
K170233 |
Device Name |
Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) |
Applicant |
Zhanjiang Star Enterprise Co., Ltd |
NO.1, West Jinhua Rd. |
Zhanjiang,
CN
524094
|
|
Applicant Contact |
Rongsheng Tang |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd |
Room 1122, No.55 Shizhou Middle Road, Nanshan District |
Shenzhen,
CN
gd755
|
|
Correspondent Contact |
Elly Xu |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/25/2017 |
Decision Date | 10/13/2017 |
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
|
|
|