Addition of French Language (translation) - New 510(k) required?

[endlesslovehv]

the product is now intended to be sold in France. Addition of French language (translation) to the multi-lingual directions for use. Would this change require a new 510(k)?

 

[MIREGMGR]

My understanding would be no, if there are no changes to the English content.

For verification, you could call US FDA DSMICA.