The following data is part of a premarket notification filed by Wuxi Yushou Medical Applicances Co., Ltd with the FDA for Safety Hypodermic Needles With/without Syringe.
| Device ID | K130212 |
| 510k Number | K130212 |
| Device Name: | SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 215# XIGANG ROAD DONGBEITANG Wuxi City, Jingsu, CN 214191 |
| Contact | Garfield Wang |
| Correspondent | Garfield Wang WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 215# XIGANG ROAD DONGBEITANG Wuxi City, Jingsu, CN 214191 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-11-20 |
| Summary: | summary |