The following data is part of a premarket notification filed by Shenzhen Ant Hi-tech Industrial Co., Ltd with the FDA for Ant Angiographic Syringes, Model(s) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301.
| Device ID | K072696 |
| 510k Number | K072696 |
| Device Name: | ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 |
| Classification | Injector And Syringe, Angiographic |
| Applicant | SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD SUITE 8D, ZHONGXIN ZHONGSHAN NO.19, LANE 999 ZHONGSHAN NO.2 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD SUITE 8D, ZHONGXIN ZHONGSHAN NO.19, LANE 999 ZHONGSHAN NO.2 Shanghai, CN 200030 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-24 |
| Decision Date | 2008-05-02 |
| Summary: | summary |