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pendragon8062

09/23/10 1:12 AM

#27509 RE: billib99 #27508

The 510k number is not made public until an SE decision is made.
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IMGGorBust

09/23/10 1:33 AM

#27510 RE: billib99 #27508

The FDA does not publicize any information about pending applications. The only devices for which you can find any information on the FDA's site or any other public sites reporting about FDA 510(k) applications are approved/cleared devices. The process is confidential until a final determination is made by the FDA.