Thursday, November 24, 2016 2:23:01 PM
Here is what Ed said re: FDA approval from the 2013 10-K:
http://www.medizoneint.com/wp-content/uploads/medizone10k123113.pdf
the classification:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=2534
the requirements for Class I exempt devices (links at the bottom):
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm
Cogmedix FDA establishment registration can be found here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
IMO the Asepticsure device listing should appear there as well
http://www.medizoneint.com/wp-content/uploads/medizone10k123113.pdf
the classification:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=2534
the requirements for Class I exempt devices (links at the bottom):
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm
Cogmedix FDA establishment registration can be found here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
IMO the Asepticsure device listing should appear there as well
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