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510(k) FDA Premarket Notification K250255

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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
27290113781195 K250255 000
17290113781402 K250255 000
17290113781389 K250255 000
17290113781365 K250255 000
17290113781341 K250255 000
17290113781327 K250255 000
17290113781303 K250255 000
17290113781280 K250255 000
07290113781252 K250255 000
07290113781122 K250255 000
17290113781426 K250255 000
17290113781440 K250255 000
27290113781164 K250255 000
07290113781665 K250255 000
07290113781658 K250255 000
07290113781641 K250255 000
07290113781634 K250255 000
07290113781627 K250255 000
07290113781610 K250255 000
17290113781488 K250255 000
17290113781464 K250255 000
07290113781115 K250255 000

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Line Number: 156

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