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510(k) FDA Premarket Notification K240884

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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
00850004850619 K240884 000
00850004850718 K240884 000
00850004850701 K240884 000
00850004850695 K240884 000
00850004850688 K240884 000
00850004850671 K240884 000
00850004850664 K240884 000
00850004850657 K240884 000
00850004850640 K240884 000
00850004850633 K240884 000
00850004850626 K240884 000
00850004850886 K240884 000
00850004850725 K240884 000
00850004850732 K240884 000
00850004850749 K240884 000
00850004850855 K240884 000
00850004850848 K240884 000
00850004850831 K240884 000
00850004850824 K240884 000
00850004850817 K240884 000
00850004850800 K240884 000
00850004850794 K240884 000
00850004850787 K240884 000
00850004850770 K240884 000
00850004850763 K240884 000
00850004850756 K240884 000
00850004850879 K240884 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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