The following data is part of a premarket notification filed by Shenyang Mastech Medical Device Co., Ltd. with the FDA for Sterile Disposable Syringes.
| Device ID | K172694 |
| 510k Number | K172694 |
| Device Name: | Sterile Disposable Syringes |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Shenyang MasTech Medical Device Co., Ltd. Zhaojia Village, Qianjin Street Dadong District Shenyang, CN 110165 |
| Contact | Liu Han |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-07 |
| Decision Date | 2018-07-06 |
| Summary: | summary |