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BuyMyAsk

11/29/10 11:28 AM

#32879 RE: Denunzio36 #32856

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?