You-have-any-company-statements-that-refute-FDA-rejection-of-510k- submitted back in August?
Historical company precedence of not disclosing FDA status suggests higher probability of denial or similar than "put a stamp on it and send in the mail" or "no reason why we should not have clearance by end of year 2015"
IE: Company has established a precedence of not being credible and hiding information from investors