S
Hi all,
I'm in the midst of a 510(k) submission for a Class I device, and just working through an additional information request. I know where, when, how, all that - but not how many copies of the material. Everything else (submission itself, establishment registration, etc) all have a specific number of copies defined. But not additional info request.
So, anybody know if it's one or two? (can't see it being more, surely)
PS Great set of forums - my first post here, but I've never actually had to ask anything - always been able to find the answer somewhere. Pats on the back for all the knowledgeable people that answer things here
I'm in the midst of a 510(k) submission for a Class I device, and just working through an additional information request. I know where, when, how, all that - but not how many copies of the material. Everything else (submission itself, establishment registration, etc) all have a specific number of copies defined. But not additional info request.
So, anybody know if it's one or two? (can't see it being more, surely)
PS Great set of forums - my first post here, but I've never actually had to ask anything - always been able to find the answer somewhere. Pats on the back for all the knowledgeable people that answer things here
