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510(k) FDA Premarket Notification K210554

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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
08033390148573 K210554 000
08033390145398 K210554 000
08033390145404 K210554 000
08033390145411 K210554 000
08033390145428 K210554 000
08033390145435 K210554 000
08033390145442 K210554 000
08033390145459 K210554 000
08033390145466 K210554 000
08033390145381 K210554 000
08033390144995 K210554 000
08033390144919 K210554 000
08033390144926 K210554 000
08033390144933 K210554 000
08033390144940 K210554 000
08033390144957 K210554 000
08033390144964 K210554 000
08033390144971 K210554 000
08033390144988 K210554 000
08033390145473 K210554 000
08033390148382 K210554 000
08033390148498 K210554 000
08033390148504 K210554 000
08033390148511 K210554 000
08033390148528 K210554 000
08033390148535 K210554 000
08033390148542 K210554 000
08033390148559 K210554 000
08033390148566 K210554 000
08033390148481 K210554 000
08033390148474 K210554 000
08033390148399 K210554 000
08033390148405 K210554 000
08033390148412 K210554 000
08033390148429 K210554 000
08033390148436 K210554 000
08033390148443 K210554 000
08033390148450 K210554 000
08033390148467 K210554 000
08033390144902 K210554 000

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Line: 156
Function: _error_handler


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