Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
More FDA Info for this Device |
510(K) Number |
K201866 |
Device Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
Applicant |
Bain Medical Equipment(Guangzhou) Co., Ltd.
No.10, Juncheng Road, Eastern Area,
Economic and Technological Development
Guangzhou 510760 CN
Other 510(k) Applications for this Company
|
Contact |
Zoe Zeng
Other 510(k) Applications for this Contact |
Regulation Number |
876.5820
More FDA Info for this Regulation Number |
Classification Product Code |
FJK
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/07/2020 |
Decision Date |
03/10/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
GU - Gastroenterology & Urology |
Review Advisory Committee |
GU - Gastroenterology & Urology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|