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Re: None

Saturday, 01/08/2022 11:48:35 PM

Saturday, January 08, 2022 11:48:35 PM

Post# of 31325
How long is a 510(k) review?
Almost two out of threel 510 (k) applications are cleared within six months. Although the FDA sets goals to review and respond to 510 (k) submissions within 90 days, it is an uncommon occurrence thanks to the time required for you to respond to additional information (AI) requests

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