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Re: mtoronto post# 164112

Sunday, 12/09/2018 2:51:38 AM

Sunday, December 09, 2018 2:51:38 AM

Post# of 330302

1) 510K resubmission
2) Meeting with the FDA
3) Last but not least, communications through e-mails and telephone conversations may also clear the product.

The NSE was based on the evidence that was submitted in the 510K.



Does this mean the rejection is not final yet?