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Hello everyone,
I am preparing my tradditional 510(k), until the 9th part for 510(k),I find the declarations of conformity requirement.and in the guidance document,it says the declarations of conformity is for abbreviated 510(k)s. So I want to know if I should submit declarations of conformity for my traditional 510(k)?
If I have to submit declarations of conformity for my tradditional 510(k) for our ESU, a IIb class product, who could provide me a template of declarations of conformity?
Waiting for good news. Anyone who can give suggestion is appreciated.

I am preparing my tradditional 510(k), until the 9th part for 510(k),I find the declarations of conformity requirement.and in the guidance document,it says the declarations of conformity is for abbreviated 510(k)s. So I want to know if I should submit declarations of conformity for my traditional 510(k)?
If I have to submit declarations of conformity for my tradditional 510(k) for our ESU, a IIb class product, who could provide me a template of declarations of conformity?
Waiting for good news. Anyone who can give suggestion is appreciated.

