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510(k) FDA Premarket Notification K233779

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The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

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Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16975339622128 K233779 000
16975339622142 K233779 000
16975339622159 K233779 000
16975339622166 K233779 000
16975339622173 K233779 000
16975339622180 K233779 000
16975339622197 K233779 000
16975339622203 K233779 000
16975339622210 K233779 000
16975339622227 K233779 000
16975339622234 K233779 000
16975339622135 K233779 000

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