Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K181870 |
Device Name |
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use |
Applicant |
Wuhan W.E.O Science & Technology Development Co., Ltd. |
No.18, Huanhu Mid. Rd., Jinyin Lake, Dongxihu Dist |
Wuhun,
CN
430040
|
|
Applicant Contact |
Chengling Fu |
Correspondent |
Mid-Link Consulting Co., Ltd. |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/12/2018 |
Decision Date | 02/26/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|