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Redacted 510(k)s - Example wanted

Dobby1979

Involved In Discussions
#1
Hi All.

Does anyone have a redacted (not to the FDA level) submission that they would be willing to share? I am moving closer to my first submission and I would like to compare against something to see if I am adding too much or too little detail!

I appreciate that all submissions are different but if anybody has anything, it would be a great help.

Please feel free to private message rather than post on here if you can help at all.

Thanks
 

Dobby1979

Involved In Discussions
#3
Hi Al.

Thanks for the link but the redacted 510k's listed on the FDA are too.......redacted! Obviously a big a ask but was hoping that someone might a submission that they could share privatley so I could compare, make sure I had not missed anything major and had the right level of detail etc.
 

Al Rosen

Staff member
Super Moderator
#4
Hi Al.

Thanks for the link but the redacted 510k's listed on the FDA are too.......redacted! Obviously a big a ask but was hoping that someone might a submission that they could share privatley so I could compare, make sure I had not missed anything major and had the right level of detail etc.
It's unlikely someone would share that.
 

Al Rosen

Staff member
Super Moderator
#7
Hi Dobby,

you can contact me via email or my website. I can´t give you an example, but maybe there´s another way that could help.

Kind regards
thinqbetter
What is another way? Rather than keeping it private, please explain it in the thread so others are helped as well. We're here to share, not sell.
 

Dobby1979

Involved In Discussions
#9
I think you have misunderstood me saying ‘generous’ as meaning I am asking for someone to sell me this! I was meaning in a light hearted way that someone might be willing to share a redacted a file that they had.
I have my 20 (well 21actually) but I don’t know if I have included enough detail or not formatted in a correct way. We are a small company and don’t have the money to involve consultants, yet we want to try and ensure the submission goes as smoothly as possible. I just thought someone might have a redacted submission that gave enough detail to be useful as the ones on the FDA website do not really help in my opinion.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
I think you have misunderstood me saying ‘generous’ as meaning I am asking for someone to sell me this! I was meaning in a light hearted way that someone might be willing to share a redacted a file that they had.
I have my 20 (well 21actually) but I don’t know if I have included enough detail or not formatted in a correct way. We are a small company and don’t have the money to involve consultants, yet we want to try and ensure the submission goes as smoothly as possible. I just thought someone might have a redacted submission that gave enough detail to be useful as the ones on the FDA website do not really help in my opinion.
Yup, unicorns abound.
Sorry, scratch that.
We're here to share, not sell.
Al,

I'm here to share and help (and the record would prove that), but there's only a fine line between "generous" sharing and rude abuse of good will. If I (or anyone) have put in a lot of time and work into preparing something (not to mention years of learning things the hard way), I don't necessarily want to give it away as a freebie but I might be open to negotiating a fair compensation for my efforts, should anyone be interested. The fact that someone didn't plan or budget properly and "doesn't have money" is not particularly moving as far as I'm concerned. Sorry if that's too harsh on anyone.

To me the key word is "fair".
 
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