The following data is part of a premarket notification filed by Shenzhen Boon Medical Supply Co., Ltd with the FDA for Sterile High-pressure Angiographic Syringes For Single-use.
| Device ID | K192657 |
| 510k Number | K192657 |
| Device Name: | Sterile High-pressure Angiographic Syringes For Single-use |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Shenzhen Boon Medical Supply Co., Ltd No 6 Shenkeng Road, Shenkeng Industrial Zon Liuyue Community Henggang Shenzhen, CN 518173 |
| Contact | Mingan Mu |
| 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 | 2019-09-25 |
| Decision Date | 2020-08-07 |