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Re: Denunzio36 post# 32856

Monday, 11/29/2010 11:28:40 AM

Monday, November 29, 2010 11:28:40 AM

Post# of 59551
Agreed. The FDA consulting firm knows what will and will not get 510(K) approval. If they allow the submission you can get there is a greater than 50% chance it will get approved this time around.

The questions now are:

1.) How long will this take to submit to the FDA?

2.) How much dilution will occur?