K241378
- 510(k) number
- K241378
- Device name
- S.I.N. Instrument Kits
- Applicant
- S.I.N. - Sistema DE Implante Nacional S.A. BR
- Product code
- KCT — Sterilization Wrap Containers, Trays, Cassettes & Ot
- Decision date
- 2024-07-12
- Date received
- 2024-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K241378.pdf
Official FDA record: K241378
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.