K243475
- 510(k) number
- K243475
- Device name
- Chemical Indicator for enspire CLCSPS (LCC015)
- Applicant
- STERIS Corporation OH · US
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2024-12-04
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243475.pdf
Official FDA record: K243475
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.