Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K112204 |
Device Name |
KDL DISPOSABLE INFUSION SET |
Applicant |
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. |
P.O. BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Applicant Contact |
Diana Hong |
Correspondent |
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. |
P.O. BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/01/2011 |
Decision Date | 09/10/2012 |
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
|
|
|