The following data is part of a premarket notification filed by Double Medical Technology Inc. with the FDA for Double Medical Femoral Nail System.
| Device ID | K172830 |
| 510k Number | K172830 |
| Device Name: | Double Medical Femoral Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Double Medical Technology Inc. No. 18, Shanbianhong East Road, Haicang District Xiamen, CN |
| Contact | Yan Zuo |
| Correspondent | Yan Zuo Double Medical Technology Inc. No. 18, Shanbianhong East Road, Haicang District Xiamen, CN |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-08-24 |
| Summary: | summary |