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Re: stockdarockk post# 147081

Tuesday, 07/24/2018 10:47:25 PM

Tuesday, July 24, 2018 10:47:25 PM

Post# of 331278
To say WRONG is to disagree with the FDA guidelines as outlined. Here is a link to help gain a better understanding. It's in black and white. FDA clearances are based on safety and effectiveness.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
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