S
I am trying to understand who needs to submit a 510(k) in this situation.
I company in China is manufacturing a Class II medical device for an Orthodontist here in the United States. The Orthodontist intends to market and sell these devices in the U.S.
Is the Manufacturer selling to the Orthodontist required to have a 510(k) to sell them to the Ortho in the U.S.?
I company in China is manufacturing a Class II medical device for an Orthodontist here in the United States. The Orthodontist intends to market and sell these devices in the U.S.
Is the Manufacturer selling to the Orthodontist required to have a 510(k) to sell them to the Ortho in the U.S.?