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Update 09-06-2010

September 6th, 2010

GardMin Engineering LLC applied for FDA 510K approval for our LifeChoiceToday at-home insemination syringe on June 1st, 2010.  GardMin Engineering LLC recently received correspondence from the FDA including instructions detailing clinical trials we would need to complete in order to market the syringe as an at-home use device.  The FDA recommended that the LifeChoiceToday syringe be a prescription use only device.  GardMin Engineering LLC is awaiting proposals for the clinical testing.

GardMin Engineering Updates

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