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510(k) FDA Premarket Notification K251654

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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
30382903829577 K251654 000
50382903818674 K251654 000
50382903818575 K251654 000
30382903818540 K251654 000
50382903818476 K251654 000
30382903818373 K251654 000
30382903818335 K251654 000
50382903810579 K251654 000
50382903810548 K251654 000
30382903810476 K251654 000
30382903810445 K251654 000
30382903810377 K251654 000
30382903810346 K251654 000
30382903810339 K251654 000
30382903810247 K251654 000
30382903810230 K251654 000
30382903819127 K251654 000
50382903819237 K251654 000
50382903819336 K251654 000
50382903829540 K251654 000
50382903829472 K251654 000
30382903829447 K251654 000
30382903829379 K251654 000
50382903829342 K251654 000
30382903829331 K251654 000
30382903829249 K251654 000
30382903829232 K251654 000
50382903829120 K251654 000
50382903819572 K251654 000
50382903819541 K251654 000
30382903819479 K251654 000
30382903819448 K251654 000
30382903819370 K251654 000
50382903819343 K251654 000
30382903810124 K251654 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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