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510(k) FDA Premarket Notification K251725

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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
08800308490099 K251725 000
08800037598448 K251725 000
08800037598431 K251725 000
08800037598424 K251725 000
08800037598417 K251725 000
08800037598400 K251725 000
08800037598394 K251725 000
08800037598387 K251725 000
08800037598370 K251725 000
08800037598363 K251725 000
08800037598356 K251725 000
08800037598332 K251725 000
08800037598318 K251725 000
08800037598301 K251725 000
08800037598295 K251725 000
08800037598288 K251725 000
08800037598271 K251725 000
08800037598455 K251725 000
08800037598462 K251725 000
08800037598479 K251725 000
08800308490082 K251725 000
08800308490075 K251725 000
08800308490068 K251725 000
08800308490051 K251725 000
08800308490044 K251725 000
08800308490037 K251725 000
08800308490020 K251725 000
08800308490013 K251725 000
08800037598554 K251725 000
08800037598547 K251725 000
08800037598530 K251725 000
08800037598523 K251725 000
08800037598516 K251725 000
08800037598509 K251725 000
08800037598493 K251725 000
08800037598486 K251725 000
08800037598264 K251725 000

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