OJI · Burn Kit With Drug
· Class N
Overview
| Product Code | OJI |
|---|---|
| Device Name | Burn Kit With Drug |
| Device Class | Class N |
| Review Panel |
Identification
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
