This message was posted by a user wishing to remain anonymous
Hello All,
I could use some guidance with the "Activities for Listings" section on the FDA website for a Class II 510(k)
Background
We design dental abutment blanks that have a 510(k) manufactured by a contract manufacturer and shipped back to us for use as a manufacturing material (component) at our facility. The component is then sent to a customer that produces the finished device.
In the "Activities for Listing(s)" section in our FDA account are several activities that can be selected for this particular 510(k).
I have checked the following activity:
- Develop specifications but do not manufacturer at this facility
I am not sure if the activity below would also be applicable
- Manufacturer Medical Device
Since we do not manufacturer the finished device (only a component), would I select the activity "Manufacturer Medical Device"?
Thank you in advance for any advise.