K233777
- 510(k) number
- K233777
- Device name
- PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- Applicant
- Primed Medical Products, Inc. CA
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2024-05-24
- Date received
- 2023-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233777.pdf
Official FDA record: K233777
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.