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05/18/17 9:32 AM

#6282 RE: 21money21 #6276

One question I have been pondering, is, CE Mark is most often easier to obtain than FDA approval. That's why many new products try for CE Mark prior to FDA application. So.. Whatever glitch occurred with CE Mark application, will there be same issue with 510 k application? Until I hear bad news, I'll take the silence of management in stride and give the company the benefit of doubt, for now. I am a little surprised however, That there hasn't been any word on new trials or mention of new applications etc. we shall see ( and hope for a positive outcome). Glta