K232080
- 510(k) number
- K232080
- Device name
- Puracyn® Plus Antimicrobial Irrigation Solution
- Applicant
- Innovacyn, Inc. CA · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-05-31
- Date received
- 2023-07-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K232080.pdf
Official FDA record: K232080
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.