Device, Electrical Dental Anesthesia
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Multi-Concept Interconnect Solutions Co., Ltd. Guangdong, contract manufacturer
How Is LWM Classified?
Device, Electrical Dental Anesthesia is FDA product code LWM, unclassified.
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. 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.
Name
Record