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Re: Tz3sports post# 30825

Tuesday, 05/31/2022 9:19:44 AM

Tuesday, May 31, 2022 9:19:44 AM

Post# of 31420
i know the process, i work for a cardiac device company and our device took 5 years to be approved through PMA, so, yes a 510k can take several years. Maybe RMSLs is different because of the information FDA was requesting but stay in your lane buddy because ive been doing this as my job for years and yearsssssssssss
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