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510(k) FDA Premarket Notification K253236

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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
08445644003505 K253236 000
08445644003529 K253236 000
08445644003512 K253236 000
08445644003383 K253236 000
08445644003376 K253236 000
08445644003369 K253236 000
08445644003352 K253236 000
08445644003345 K253236 000
08445644003338 K253236 000
08445644003321 K253236 000
08445644003314 K253236 000
08445644003307 K253236 000
08445644003291 K253236 000
08445644003284 K253236 000
08445644003277 K253236 000
08445644003260 K253236 000
08445644003253 K253236 000
08445644003536 K253236 000
08445644003543 K253236 000
08445644003499 K253236 000
08445644003482 K253236 000
08445644003475 K253236 000
08445644003468 K253236 000
08445644003451 K253236 000
08445644003444 K253236 000
08445644003437 K253236 000
08445644003420 K253236 000
08445644003413 K253236 000
08445644003406 K253236 000
08445644003390 K253236 000
08445644003239 K253236 000
08445644003222 K253236 000
08445644003215 K253236 000
08445644003567 K253236 000
08445644003550 K253236 000
08445644003246 K253236 000

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Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
Function: _error_handler


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