The following data is part of a premarket notification filed by Beijing Wantefu Medical Apparatus Co., Ltd. with the FDA for Wtf Secura Syringe And Needle.
| Device ID | K132120 |
| 510k Number | K132120 |
| Device Name: | WTF SECURA SYRINGE AND NEEDLE |
| Classification | Syringe, Piston |
| Applicant | BEIJING WANTEFU MEDICAL APPARATUS CO., LTD. NANTOU INDUSTRIAL PARK MACHIKOU Beijing, CN 102200 |
| Contact | Raymond Sun |
| Correspondent | Raymond Sun BEIJING WANTEFU MEDICAL APPARATUS CO., LTD. NANTOU INDUSTRIAL PARK MACHIKOU Beijing, CN 102200 |
| Product Code | FMF |
| Subsequent Product Code | FMI |
| Subsequent Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-09 |
| Decision Date | 2013-12-12 |
| Summary: | summary |