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Eli's Gone

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Re: never-say-die post# 37218

Tuesday, 10/28/2014 11:13:36 AM

Tuesday, October 28, 2014 11:13:36 AM

Post# of 52074
According to the company---and I am assuming this is based on information from the FDA---as a Class 1 Exempt device, Asepticsure will only need to be registered with the FDA and labeled-requiring no premarket 510(k) FDA review...

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194468.htm

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