OJI — Burn Kit With Drug Class N
FDA product code OJI covers "Burn Kit With Drug", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OJI
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.