510(k) submission - Which name should I use in the submission?

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Tiffany88

Registered
#1
#1
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
 
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shimonv

shimonv

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#2
#2
The name of the legal entity, which is the one that appears on the IFU, label, and software (if used) - should appear in the 510(k) application. And, of course, to get the discount for small businesses - it should match the details on the Small Business designation application.
 
Watchcat

Watchcat

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#3
#3
I think the name on the submission mostly identifies legal responsibility for the accuracy of the information in the submission and not much else. I think the submitter also has to be legally able to submit an application for the device (i.e., owns the IP or has licensed it).

The original submitter might never even be manufacture the device for the market, once it is cleared, if they are a startup that is acquired shortly after clearance. So the manufacturing site is not that important. It is important later, when it is manufacturing an FDA-cleared device for sale on the US market. But then it will registered as an Establishment, which is a separate thing from a 510(k) applicant.
 
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