Device Classification Name |
syringe, piston
|
510(k) Number |
K081241 |
Device Name |
WEIGAO EMPTY CARTRIDGE SYRINGE |
Applicant |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
SUITE 8D, NO.19, LANE 999 |
ZHONGSHAN NO.2 ROAD(S) |
SHANGHAI,
CN
200030
|
|
Applicant Contact |
Diana Hong |
Correspondent |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
SUITE 8D, NO.19, LANE 999 |
ZHONGSHAN NO.2 ROAD(S) |
SHANGHAI,
CN
200030
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 05/01/2008 |
Decision Date | 09/08/2008 |
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
|
|
|