# Burn Kit With Drug
> **Product code: OJI** · Not classified · Unknown · —
## Classification
- **FDA Product Code:** OJI
- **Device class:** Not classified
- **Regulation:** —
- **Review panel:** SU
- **Medical specialty:** Unknown
- **Submission type:** 3
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OJI)
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