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510(k) FDA Premarket Notification K221698

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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
00850010429441 K221698 000
00850010429236 K221698 000
00850010429229 K221698 000
00850010429212 K221698 000
00850010429199 K221698 000
00850010429625 K221698 000
00850010429618 K221698 000
00850010429601 K221698 000
00850010429595 K221698 000
00850010429588 K221698 000
00850010429571 K221698 000
00850010429564 K221698 000
00850010429557 K221698 000
00850010429243 K221698 000
00850010429250 K221698 000
00850010429427 K221698 000
00850010429410 K221698 000
00850010429403 K221698 000
00850010429373 K221698 000
00850010429366 K221698 000
00850010429359 K221698 000
00850010429342 K221698 000
00850010429335 K221698 000
00850010429311 K221698 000
00850010429298 K221698 000
00850010429281 K221698 000
00850010429267 K221698 000
00850010429533 K221698 000

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Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 156
Function: _error_handler


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