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510(k) FDA Premarket Notification K240299

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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
00889024650572 K240299 000
00889024646544 K240299 000
00889024646537 K240299 000
00889024646520 K240299 000
00889024646513 K240299 000
00889024646506 K240299 000
00889024646483 K240299 000
00889024646476 K240299 000
00889024646469 K240299 000
00889024646452 K240299 000
00889024646445 K240299 000
00889024646599 K240299 000
00889024646377 K240299 000
00889024650565 K240299 000
00889024650558 K240299 000
00889024650541 K240299 000
00889024650534 K240299 000
00889024650527 K240299 000
00889024646490 K240299 000
00889024646414 K240299 000
00889024646407 K240299 000
00889024646391 K240299 000
00889024646384 K240299 000
00889024646438 K240299 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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