The following data is part of a premarket notification filed by Union Medical Shenzhen Co., Ltd. with the FDA for Disposable High Pressure Syringe.
| Device ID | K170279 |
| 510k Number | K170279 |
| Device Name: | Disposable High Pressure Syringe |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Union Medical Shenzhen Co., Ltd. Room 603, Building 3, Fantasia MIC Plaza, Nanhai Avenue Nanshan District Shenzhen, CN 518062 |
| Contact | Wenguo Zhang |
| 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 | 2017-01-30 |
| Decision Date | 2017-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970286900438 | K170279 | 000 |
| 10850014500211 | K170279 | 000 |
| 10850014500204 | K170279 | 000 |
| 10850014500198 | K170279 | 000 |
| 10850014500181 | K170279 | 000 |
| 10850014500174 | K170279 | 000 |
| 10850014500167 | K170279 | 000 |
| 10850014500150 | K170279 | 000 |
| 10850014500143 | K170279 | 000 |
| 10850014500136 | K170279 | 000 |
| 10850014500129 | K170279 | 000 |
| 10850014500112 | K170279 | 000 |
| 20850014500096 | K170279 | 000 |
| 10850014500075 | K170279 | 000 |
| 10850014500051 | K170279 | 000 |
| 10850014500037 | K170279 | 000 |
| 10850014500228 | K170279 | 000 |
| 06970286900315 | K170279 | 000 |
| 06970286900483 | K170279 | 000 |
| 06970286900407 | K170279 | 000 |
| 06970286900391 | K170279 | 000 |
| 06970286900476 | K170279 | 000 |
| 06970286900469 | K170279 | 000 |
| 06970286900452 | K170279 | 000 |
| 06970286900384 | K170279 | 000 |
| 06970286900445 | K170279 | 000 |
| 06970286900421 | K170279 | 000 |
| 06970286900414 | K170279 | 000 |
| 06970286900360 | K170279 | 000 |
| 06970286900353 | K170279 | 000 |
| 06970286900377 | K170279 | 000 |
| 06970286900339 | K170279 | 000 |
| 06970286900322 | K170279 | 000 |
| 10850014500013 | K170279 | 000 |