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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

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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

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

A PHP Error was encountered

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Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

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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: 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 K243934

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Backtrace:

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Function: _error_handler

A PHP Error was encountered

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Message: Undefined index: classificationName

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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: 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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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: 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

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

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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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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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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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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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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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Message: Undefined index: correspondentContact

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Line Number: 85

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: 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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Message: Undefined index: classificationPC

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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: subsequentPC

Filename: fda.report/pmn_item.php

Line Number: 90

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: regulationNumber

Filename: fda.report/pmn_item.php

Line Number: 95

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: decision

Filename: fda.report/pmn_item.php

Line Number: 99

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: regulationMS

Filename: fda.report/pmn_item.php

Line Number: 100

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: 501kReviewPanel

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Line Number: 103

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: fdaReview

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Line Number: 106

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: fdaReview

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Line Number: 107

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 107
Function: _error_handler

A PHP Error was encountered

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Message: Undefined index: type

Filename: fda.report/pmn_item.php

Line Number: 109

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 109
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: thirdPartyReviewed

Filename: fda.report/pmn_item.php

Line Number: 110

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 110
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: combinationProduct

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Line Number: 111

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 111
Function: _error_handler

A PHP Error was encountered

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Message: Undefined index: dateReceived

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Line Number: 112

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 112
Function: _error_handler

A PHP Error was encountered

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Message: Undefined index: decisionDate

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Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 113
Function: _error_handler

A PHP Error was encountered

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Message: Undefined index: summary

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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

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Message: Undefined index: deviceName

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Line Number: 156

Backtrace:

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


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