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,
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,