Instrument, Dowel Cutting
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong.
- Fuji Dynamics Limited Guangdong
How Is GZQ Classified?
Instrument, Dowel Cutting is FDA product code GZQ, Class 2, 21 CFR 882.4275.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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