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510(k) FDA Premarket Notification K242907

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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
08809698710466 K242907 000
08809558739606 K242907 000
08809558739590 K242907 000
08809558739521 K242907 000
08809558739491 K242907 000
08800270919901 K242907 000
08800270919895 K242907 000
08800270913107 K242907 000
08800270913091 K242907 000
08809558739996 K242907 000
08809560829975 K242907 000
08809698710459 K242907 000
08809698710381 K242907 000
08809698710374 K242907 000
08809698710022 K242907 000
08809698710008 K242907 000
08809624549955 K242907 000
08809624549948 K242907 000
08809624540617 K242907 000
08800267437999 K242907 000

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Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
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