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510(k) FDA Premarket Notification K250980

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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
08033390282079 K250980 000
08033390281942 K250980 000
08033390281935 K250980 000
08033390281928 K250980 000
08033390281911 K250980 000
08033390281904 K250980 000
08033390281799 K250980 000
08033390281782 K250980 000
08033390281775 K250980 000
08033390281959 K250980 000
08033390281966 K250980 000
08033390282062 K250980 000
08033390282055 K250980 000
08033390282048 K250980 000
08033390282024 K250980 000
08033390282000 K250980 000
08033390281997 K250980 000
08033390281980 K250980 000
08033390281973 K250980 000
08033390281751 K250980 000

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Line Number: 156

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