A PHP Error was encountered

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Message: Undefined index: pmaNumber

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Backtrace:

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

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

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Backtrace:

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

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

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Backtrace:

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

A PHP Error was encountered

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Message: Undefined index: deviceName

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Backtrace:

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A PHP Error was encountered

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Message: Undefined index: applicant

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Backtrace:

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

510(k) FDA Premarket Notification K232150

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Function: _error_handler

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Message: Undefined index: deviceName

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Backtrace:

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

The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

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Function: _error_handler

A PHP Error was encountered

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Function: _error_handler

A PHP Error was encountered

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A PHP Error was encountered

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A PHP Error was encountered

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A PHP Error was encountered

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A PHP Error was encountered

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Function: _error_handler

A PHP Error was encountered

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Message: Undefined index: correspondent

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Message: Undefined index: correspondentContact

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Message: Undefined index: decision

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

File: /var/www/fda.report/pmn_item.php
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A PHP Error was encountered

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A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Message: Undefined index: combinationProduct

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Backtrace:

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

A PHP Error was encountered

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Message: Undefined index: dateReceived

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

A PHP Error was encountered

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Backtrace:

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

Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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A PHP Error was encountered

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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