Hello all,
I'm almost ready to submit our first 510(k) but I have a situation that I never saw before. Our company headquarters are in US and the manufacturing office in France. The Small Business designation was done using the name and address of the headquarters, however I don't know if now I have to submit the 510(k) using the headquarters address or the manufacturing office address.
Also, the name of the company is a little different, EXAMPLE in
US: Peter Piper, Inc., d/b/a. Picked
FR: Picked a peck of pickled peppers S.L.
Witch name should I use in the submission? Remember, the small business designation was done using the US name.
Thank you
I'm almost ready to submit our first 510(k) but I have a situation that I never saw before. Our company headquarters are in US and the manufacturing office in France. The Small Business designation was done using the name and address of the headquarters, however I don't know if now I have to submit the 510(k) using the headquarters address or the manufacturing office address.
Also, the name of the company is a little different, EXAMPLE in
US: Peter Piper, Inc., d/b/a. Picked
FR: Picked a peck of pickled peppers S.L.
Witch name should I use in the submission? Remember, the small business designation was done using the US name.
Thank you