Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K090459 |
Device Name |
DISPOSABLE TPE INFUSION SET |
Applicant |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
STE.8D, ZHONGXIN ZHONGSHAN #2 |
ROADY ,NO.19, LANE 999, ZHONG |
SHAN NAN ER RD., SHANGHAI,
CN
200030
|
|
Applicant Contact |
Diana Hong |
Correspondent |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
STE.8D, ZHONGXIN ZHONGSHAN #2 |
ROADY ,NO.19, LANE 999, ZHONG |
SHAN NAN ER RD., SHANGHAI,
CN
200030
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/23/2009 |
Decision Date | 10/13/2009 |
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
|
|
|