A
Achemd
Hi all,
I am looking for some ideas on how to handle this. We currently manufacture for a company a class 1 device. They hold the 510(k) under their name. What do we need for 510(k) approval under our name?
Must we submit all the documents as if it is a new filing?
Can we reference their 510(k) and submit no supporting documents except anme and co change and perhaps labeling?
always welcome and thanks
Laurel
I am looking for some ideas on how to handle this. We currently manufacture for a company a class 1 device. They hold the 510(k) under their name. What do we need for 510(k) approval under our name?
Must we submit all the documents as if it is a new filing?
Can we reference their 510(k) and submit no supporting documents except anme and co change and perhaps labeling?
always welcome and thanks
Laurel