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ZetaReticuli

04/26/21 3:07 PM

#29814 RE: ZetaReticuli #29813

Patent approval is independent of FDA 510k clearance.

Patents protect the intellectual property of the company from infringement and has no bearing on the FDA 510k clearance which concerns public safety.

The DeltaWave 510k was just rejected at the end of November by the FDA after a six year wait time.

RMSL cannot sell, ship, or market the DeltaWave without receiving FDA 510k clearance.