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510(k) FDA Premarket Notification K253583

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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
00840493416700 K253583 000
00840493416069 K253583 000
00840493416052 K253583 000
00840493416045 K253583 000
00840493416038 K253583 000
00840493416021 K253583 000
00840493416014 K253583 000
00840493416007 K253583 000
00840493415994 K253583 000
00840493415987 K253583 000
00840493415970 K253583 000
00840493415963 K253583 000
00840493415956 K253583 000
00840493416076 K253583 000
00840493416083 K253583 000
00840493416090 K253583 000
00840493416694 K253583 000
00840493416687 K253583 000
00840493416588 K253583 000
00840493416526 K253583 000
00840493416175 K253583 000
00840493416168 K253583 000
00840493416151 K253583 000
00840493416144 K253583 000
00840493416137 K253583 000
00840493416120 K253583 000
00840493416113 K253583 000
00840493416106 K253583 000
00840493415949 K253583 000

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Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
Function: _error_handler


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