Talk:510k

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Although not quite an advert within Wikipedia, the link in the last section (to http://www.fdanews.com/wbi/cds/2637-1.html) is a link to an ad selling "how to do a 510(k) in 20 hours for $500". I would not consider this a creditable source. --ShaneNZ 20:25, 11 January 2007 (UTC)

I see nowhere that states "How to do a 510(k) in 20 hours for $500." Could you tell me where the source states that?

Regardless, there is also a journalistic article that states the same information. However, it is only accessible to subscribers of the newsletter. Given that most Wikipedia readers are not subscribers to FDAnews newsletters (I'm guessing), I chose instead to link to the other page.Jlculp 23:22, 12 January 2007 (UTC)
 * The wiki article does not say that - it states "on average, 20 hours" and links to an advertorial for a transcript that says it will inform you how to prepare a 510(k) in 20 hours (I use the word advertorial due to the fact it does not offer advice on 510(k)'s, but lists credentials, a price and three order now links: I see no information in that link that tells how or why 510(k)s take 20 hours, or how the link author knows that 510(k)'s take 20 hours). In my experience, a 510(k) will take more than 20 hours to prepare, and I suspect that somebody faced with their first 510(k) reading the article as it currently stands will be somewhat misled, and spend $410 trying to understand how it is only 20 hours.--ShaneNZ 12:17, 14 January 2007 (UTC)

The penultimate sentence I do find odd, if it is such a simple procedure why would it take 20 hours to do? Contradicts itself.

If I am right in my understanding, could this link not just be deleted. Ive read the article and saw no other problems with it --PrincessBrat 22:09, 12 January 2007 (UTC)
 * Supported. I would like to remove the link and the statement of the average time taken for a 510(k). I don't see that it adds anything to the article.--ShaneNZ 12:17, 14 January 2007 (UTC)

In the medical device marketing world, 20 hours to ready a device for marketing (which can bring in a company many millions of dollars) is not much at all--a PMA takes over 1,200 hours, on average.Jlculp 23:22, 12 January 2007 (UTC)

Note: article edited to use correct term "substantial equivalence" rather than "substantially similar". --ShaneNZ 12:17, 14 January 2007 (UTC)