K233132
- 510(k) number
- K233132
- Device name
- PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
- Applicant
- Primus Sterilizer Company, LLC FL · US
- Product code
- FLE — Sterilizer, Steam
- Decision date
- 2023-12-19
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233132.pdf
Official FDA record: K233132
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.