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510(k) FDA Premarket Notification K252352

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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
08033390251853 K252352 000
08033390202602 K252352 000
08033390202503 K252352 000
08033390202497 K252352 000
08033390202480 K252352 000
08033390202473 K252352 000
08033390202466 K252352 000
08033390202312 K252352 000
08033390202305 K252352 000
08033390202299 K252352 000
08033390201971 K252352 000
08033390191135 K252352 000
08033390050036 K252352 000
08033390050029 K252352 000
08033390002257 K252352 000
08033390002240 K252352 000
08033390202619 K252352 000
08033390202626 K252352 000
08033390250498 K252352 000
08033390250306 K252352 000
08033390250290 K252352 000
08033390248631 K252352 000
08033390248624 K252352 000
08033390248617 K252352 000
08033390248600 K252352 000
08033390248594 K252352 000
08033390248587 K252352 000
08033390248563 K252352 000
08033390248556 K252352 000
08033390248433 K252352 000
08033390202657 K252352 000
08033390202640 K252352 000
08033390202633 K252352 000
08033390002233 K252352 000

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Filename: fda.report/pmn_item.php

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Line: 156
Function: _error_handler


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