K230305
- 510(k) number
- K230305
- Device name
- THE Graft Collagen
- Applicant
- Purgo Biologics, Inc. KR
- Product code
- NPM — Bone Grafting Material, Animal Source
- Decision date
- 2024-07-24
- Date received
- 2023-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230305.pdf
Official FDA record: K230305
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.