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JNdouble1

02/12/19 9:22 AM

#171216 RE: toohot #171215

a "drive thru" approval



Is that a new category of 510K submission I am not aware of. Maybe part of the FDA's effort to modernize the process.

Or maybe we've learned nothing over the last many years. Let's begin the countdown, I call June 10th for the rejection of the womens application. October 15th for the rejection of Recovery RX.