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arnoldb

06/29/16 9:30 PM

#19982 RE: Groveman1 #19981

They were ready to apply for the CE Mark back in 2010, Just type in First warning System CE Mark in Google and you will see every time that they were supposed to file. You don't need to even have clinical trials or FDA clearance to get a CE Mark. Jim Holmes has done it before!! Say what you will about Holmes he has actually got things done in the past. Royea has no balls.

http://www.businesswire.com/news/home/20031209005505/en/Lifeline-BioTechnologies-Receives-CE-Mark-Certification-Duct

Dr. William Reeves, president and founder of Lifeline BioTechnologies, commented, "Now that the CE Mark certificate has been achieved for the Nipple Endoscope(TM), the company will prepare the appropriate information needed for FDA 510K notification for the technology required for the U.S. market."