BrachyGel Vaginal Hydrogel Packing System— 510(k) DEN220052
UnknownBrachyfoam, Inc. D/B/A Advaray
FDA 510(k) clearance DEN220052 for BrachyGel Vaginal Hydrogel Packing System, Unknown on 2023-08-22. Applicant: Brachyfoam, Inc. D/B/A Advaray. Device class: 2.
Clearance details
- Applicant
- Brachyfoam, Inc. D/B/A Advaray
- Product code
- Code QXR
- Device class
- Class 2
- Regulation
- 21 CFR 892.5735
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Charlottesville, VA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.