I have to say: no idea for FDA. So some folks here can help me answer this question, or give me some reference? :thanx:

Describe the contents of a FDA 510(k) submission for a medical device on the premise that there is a predicate device.

I have to say: no idea for FDA. So some folks here can help me answer this question, or give me some reference? :thanx:

Describe the contents of a FDA 510(k) submission for a medical device on the premise that there is a predicate device.
Try here http://www.fda.gov/cdrh/manual/510kprt1.html#content

You can also get a copy of the 510k of a predicate device. http://www.fda.gov/cdrh/foicdrh.html

after looking up the 510k here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

The regulations are found here:
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr807_01.html

It is not simple and depends on class and type of device. Also, the FDA has many guidance documents including the 510k content of specfic devices.

Try searching the FDA and CDRH web sites:
http://www.fda.gov/cdrh/index.html

If you have a specific question post it, and I will try to help.