Cushion, Hemorrhoid
Who Makes This Device Type in China?
4 manufacturers in China hold an FDA registration for this device type, concentrated in Fujian, Guangdong and Hunan, and 1 other province.
How Is LRL Classified?
Cushion, Hemorrhoid is FDA product code LRL, unclassified.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
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