510(k) DEN220052
- Device
- BrachyGel Vaginal Hydrogel Packing System
- Applicant
- Brachyfoam, Inc. D/B/A Advaray
- 510(k) number
- DEN220052
- Product code
- QXR
- Decision
- Unknown (DENG)
- Decision date
- 2023-08-22
- Date received
- 2022-08-25
- Regulation
- 892.5735
- Classification name
- Vaginal Hydrogel Packing System
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Timothy Showalter, MD, MPH
- Address
- 722 Preston Ave. Suite 108 Charlottesville VA US 22903 22903
FDA Registration Numbers#
- 3011324393
- 1932738
Source Documents#
510(k) summary PDF not indicated by FDA