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DewmBoom

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Re: clk5192 post# 147192

Wednesday, 07/25/2018 2:53:41 PM

Wednesday, July 25, 2018 2:53:41 PM

Post# of 331191
We knew from before that the 510K was traditional. So what you found out is not new. However, the 90 days are for traditional 510K that requires full review. BIEL’s 510K does not require a full review.

The answer they gave you is correct. The 90 days is the maximum number of days it takes for a traditional 510K.
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