Device Classification Name |
needle, fistula
|
510(k) Number |
K163025 |
Device Name |
DORA Disposable A.V. Fistula Needle Sets |
Applicant |
Bain Medical Equipment (Guangzhou) Co., Ltd. |
No.10 Juncheng Road |
Eastern Zone of Guangzhou E&T Development District |
Guangzhou,
CN
510760
|
|
Applicant Contact |
Sophia Shao |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O.Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 10/31/2016 |
Decision Date | 07/20/2017 |
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
|
|
|