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ZetaReticuli

05/31/22 9:18 AM

#30828 RE: Tz3sports #30825

Bingo. Seven years and still no 510k clearance:
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MouthBreather

05/31/22 9:19 AM

#30830 RE: Tz3sports #30825

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