Burn Kit With Drug
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Zhejiang.
- Rfx+care Manufacturing Co., Ltd. Zhejiang
What Is This Device?
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.
What Is FDA Product Code OJI?
Burn Kit With Drug is FDA product code OJI, not classified.
What Does It Take to Sell It in the United States?
The FDA sets no standard submission type for this code and asks the applicant to contact its device evaluation office about the route.
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