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510(k) FDA Premarket Notification K242297

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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
00840019976046 K242297 000
00840019971300 K242297 000
00840019971294 K242297 000
00840019971287 K242297 000
00840019971270 K242297 000
00840019971263 K242297 000
00840019971256 K242297 000
00840019971249 K242297 000
00840019971232 K242297 000
00840019971225 K242297 000
00840019971218 K242297 000
00840019971201 K242297 000
00840019971195 K242297 000
00840019971188 K242297 000
00840019971171 K242297 000
00840019971164 K242297 000
00840019971157 K242297 000
00840019971140 K242297 000
00840019971317 K242297 000
00840019971324 K242297 000
00840019976039 K242297 000
00840019976022 K242297 000
00840019971478 K242297 000
00840019971461 K242297 000
00840019971454 K242297 000
00840019971447 K242297 000
00840019971430 K242297 000
00840019971423 K242297 000
00840019971416 K242297 000
00840019971409 K242297 000
00840019971393 K242297 000
00840019971386 K242297 000
00840019971379 K242297 000
00840019971362 K242297 000
00840019971355 K242297 000
00840019971348 K242297 000
00840019971331 K242297 000
00840019971133 K242297 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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