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Special 510K possible? Only the packaging has changed

#1
Hi all,

We have an already cleared class IIa device and we want to sell this with an accessory. Our accessory is exempted in the US, and I was therefore thinking of submitted a special 510K explaning that only the packaging has changed, but we have same sterilization method etc. I should also state here, that the product can not undergo a "kit" according to the US definition/list of kits.

Do you think that will be possible to get this cleared as a special 510K? and do you have any thoughts about this?

Thank you in advance,
 
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