The following data is part of a premarket notification filed by Shandong Weigao Group Medical Polymer Co.,ltd. with the FDA for Weigao Empty Cartridge Syringe.
Device ID | K081241 |
510k Number | K081241 |
Device Name: | WEIGAO EMPTY CARTRIDGE SYRINGE |
Classification | Syringe, Piston |
Applicant | SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
Contact | Diana Hong |
Correspondent | Diana Hong SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-01 |
Decision Date | 2008-09-08 |
Summary: | summary |