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510(k) FDA Premarket Notification K221574

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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
G055ABMVIVS020 K221574 000
G055ABMVIVM020 K221574 000
G055ABMVIVM050 K221574 000
G055ABMVIVM060 K221574 000
G055ABMVIVM090 K221574 000
G055ABMVIVM100 K221574 000
G055ABMVIVR010 K221574 000
G055ABMVIVM030 K221574 000
G055ABMVIVM040 K221574 000
G055ABMVIVM070 K221574 000
G055ABMVIVM080 K221574 000
G055ABMVIVM110 K221574 000
G055ABMVIVM120 K221574 000
G055ABMVIVS010 K221574 000
G055ABMVIVM010 K221574 000

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