The following data is part of a premarket notification filed by Vha Dean with the FDA for Omf Asp System.
| Device ID | K220648 |
| 510k Number | K220648 |
| Device Name: | OMF ASP System |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | VHA DEAN 810 Vermont Ave NW Washington, DC 20420 |
| Contact | Beth Ripley |
| Correspondent | Laura Gilmour LG Strategies, LLC 2001 Parker Lane #122 Austin, TX 78741 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-08-11 |