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510(k) FDA Premarket Notification K252700

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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
00840303714484 K252700 000
00840303714354 K252700 000
00840303714347 K252700 000
00840303714330 K252700 000
00840303714323 K252700 000
00840303714316 K252700 000
00840303714309 K252700 000
00840303714293 K252700 000
00840303714286 K252700 000
00840303714279 K252700 000
00840303714262 K252700 000
00840303714361 K252700 000
00840303714378 K252700 000
00840303714477 K252700 000
00840303714460 K252700 000
00840303714453 K252700 000
00840303714446 K252700 000
00840303714439 K252700 000
00840303714422 K252700 000
00840303714415 K252700 000
00840303714408 K252700 000
00840303714392 K252700 000
00840303714385 K252700 000
00840303714255 K252700 000

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Filename: fda.report/pmn_item.php

Line Number: 156

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Line: 156
Function: _error_handler


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