The following data is part of a premarket notification filed by Wuxi Yushou Medical Applicances Co., Ltd with the FDA for Sterile Piston Hypodermic Syringes (with/without Needle), Hypodermic Needles.
| Device ID | K130230 |
| 510k Number | K130230 |
| Device Name: | STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES |
| Classification | Syringe, Piston |
| Applicant | WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 215# XIGANG ROAD DONGBEITANG Wuxi City, Jiangsu, CN 214191 |
| Contact | Garfield Wang |
| Correspondent | Garfield Wang WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 215# XIGANG ROAD DONGBEITANG Wuxi City, Jiangsu, CN 214191 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00370393562011 | K130230 | 000 |
| 00370393000353 | K130230 | 000 |
| 10370393140018 | K130230 | 000 |
| 00370393552012 | K130230 | 000 |
| 0037039300445 | K130230 | 000 |
| 0037039300469 | K130230 | 000 |
| 10370393557014 | K130230 | 000 |
| 00370393000537 | K130230 | 000 |
| 10370393560014 | K130230 | 000 |
| 00370393000513 | K130230 | 000 |
| 00370393000339 | K130230 | 000 |