K232646
- 510(k) number
- K232646
- Device name
- Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
- Applicant
- Cook Biotech Incorporated IN · US
- Product code
- KHJ — Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Mater
- Decision date
- 2024-05-24
- Date received
- 2023-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232646.pdf
Official FDA record: K232646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.