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510(k) FDA Premarket Notification P060019

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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
05414734309059 P060019 000
05414734308595 P060019 000
05414734308588 P060019 000
05414734308571 P060019 000
05414734308564 P060019 000
05414734306737 P060019 000
05414734306720 P060019 000
05414734306713 P060019 000
05414734306706 P060019 000
05415067019875 P060019 002
05414734309080 P060019 005
05414734258616 P060019 005
05415067008985 P060019 005
05414734310765 P060019 021
05414734310758 P060019 021
05414734310741 P060019 021
05414734310734 P060019 021
05414734310680 P060019 021
05414734310673 P060019 021
05414734310666 P060019 021
05414734310659 P060019 021
05415067016669 P060019 029

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Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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