The following data is part of a premarket notification filed by Vha Dean with the FDA for Vha Radiotherapy Bolus.
| Device ID | K222639 |
| 510k Number | K222639 |
| Device Name: | VHA Radiotherapy Bolus |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | VHA DEAN 810 Vermont Ave NW Washington, DC 20420 |
| Contact | Beth Ripley |
| Correspondent | Laura Gilmour LG Strategies, LLC 3903 S. Congress Ave #3930 Austin, TX 78704 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-01 |
| Decision Date | 2022-11-04 |