A PHP Error was encountered

Severity: Notice

Message: Undefined index: pmaNumber

Filename: fda.report/pmn_item.php

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Backtrace:

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Line: 21
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

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Backtrace:

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Line: 25
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

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Backtrace:

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Line: 25
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:

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Line: 26
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

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Backtrace:

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Line: 26
Function: _error_handler

510(k) FDA Premarket Notification K212612

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Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationName

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Line: 34
Function: _error_handler

A PHP Error was encountered

Severity: Notice

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Line: 35
Function: _error_handler

A PHP Error was encountered

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Line: 54
Function: _error_handler

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Line: 55
Function: _error_handler

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Message: Undefined index: applicant

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Line: 66
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 66

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 66
Function: _error_handler

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

Pre-market Notification Details

A PHP Error was encountered

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Message: Undefined index: deviceId

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Line Number: 78

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Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: 501kNumber

Filename: fda.report/pmn_item.php

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Line: 79
Function: _error_handler

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Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

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Line: 80
Function: _error_handler

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Severity: Notice

Message: Undefined index: classificationName

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Line: 81
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantFull

Filename: fda.report/pmn_item.php

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File: /var/www/fda.report/pmn_item.php
Line: 82
Function: _error_handler

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Severity: Notice

Message: Undefined index: applicantContact

Filename: fda.report/pmn_item.php

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Line: 83
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantContact

Filename: fda.report/pmn_item.php

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File: /var/www/fda.report/pmn_item.php
Line: 83
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondent

Filename: fda.report/pmn_item.php

Line Number: 84

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Line: 84
Function: _error_handler

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Severity: Notice

Message: Undefined index: correspondentContact

Filename: fda.report/pmn_item.php

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Backtrace:

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Line: 84
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondentContact

Filename: fda.report/pmn_item.php

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Line: 85
Function: _error_handler

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Severity: Notice

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Backtrace:

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Line: 85
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationPC

Filename: fda.report/pmn_item.php

Line Number: 87

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Line: 87
Function: _error_handler

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Severity: Notice

Message: Undefined index: subsequentPC

Filename: fda.report/pmn_item.php

Line Number: 90

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 90
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
Line: 95
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: decision

Filename: fda.report/pmn_item.php

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File: /var/www/fda.report/pmn_item.php
Line: 99
Function: _error_handler

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Severity: Notice

Message: Undefined index: regulationMS

Filename: fda.report/pmn_item.php

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Line: 100
Function: _error_handler

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Line: 103
Function: _error_handler

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Line: 106
Function: _error_handler

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Severity: Notice

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Line: 107
Function: _error_handler

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Line: 109
Function: _error_handler

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Severity: Notice

Message: Undefined index: thirdPartyReviewed

Filename: fda.report/pmn_item.php

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Line: 110
Function: _error_handler

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Severity: Notice

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Filename: fda.report/pmn_item.php

Line Number: 111

Backtrace:

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

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Severity: Notice

Message: Undefined index: dateReceived

Filename: fda.report/pmn_item.php

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Backtrace:

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

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Severity: Notice

Message: Undefined index: decisionDate

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Backtrace:

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Line: 113
Function: _error_handler

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Severity: Notice

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Line: 114
Function: _error_handler

Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843511104757 K212612 000
00843511104566 K212612 000
00843511104559 K212612 000
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00843511104306 K212612 000
00843511104290 K212612 000
00843511104283 K212612 000
00843511104276 K212612 000
00843511104269 K212612 000
00843511104252 K212612 000
00843511104245 K212612 000
00843511104238 K212612 000
00843511104221 K212612 000
00843511104214 K212612 000
00843511104207 K212612 000
00843511104191 K212612 000
00843511104573 K212612 000
00843511104580 K212612 000
00843511104740 K212612 000
00843511104733 K212612 000
00843511104726 K212612 000
00843511104719 K212612 000
00843511104702 K212612 000
00843511104696 K212612 000
00843511104689 K212612 000
00843511104672 K212612 000
00843511104665 K212612 000
00843511104658 K212612 000
00843511104641 K212612 000
00843511104634 K212612 000
00843511104627 K212612 000
00843511104610 K212612 000
00843511104603 K212612 000
00843511104597 K212612 000
00843511104184 K212612 000
00843511105181 K212612 000
00843511105174 K212612 000
00843511123505 K212612 000
00843511123499 K212612 000
00843511123482 K212612 000
00843511123475 K212612 000
00843511123468 K212612 000
00843511123451 K212612 000
00843511123444 K212612 000
00843511123437 K212612 000
00843511123420 K212612 000
00843511123291 K212612 000
00843511123284 K212612 000
00843511123277 K212612 000
00843511123260 K212612 000
00843511123253 K212612 000
00843511123246 K212612 000
00843511123239 K212612 000
00843511123512 K212612 000
00843511123529 K212612 000
00843511105167 K212612 000
00843511105150 K212612 000
00843511105143 K212612 000
00843511105136 K212612 000
00843511105129 K212612 000
00843511105112 K212612 000
00843511105105 K212612 000
00843511105099 K212612 000
00843511105082 K212612 000
00843511105075 K212612 000
00843511105068 K212612 000
00843511105051 K212612 000
00843511123567 K212612 000
00843511123550 K212612 000
00843511123543 K212612 000
00843511123536 K212612 000
00843511122751 K212612 000
00843511105037 K212612 000
00843511104511 K212612 000
00843511104504 K212612 000
00843511104498 K212612 000
00843511104481 K212612 000
00843511104474 K212612 000
00843511104467 K212612 000
00843511104450 K212612 000
00843511104443 K212612 000
00843511104436 K212612 000
00843511104429 K212612 000
00843511104412 K212612 000
00843511104405 K212612 000
00843511104399 K212612 000
00843511104382 K212612 000
00843511104375 K212612 000
00843511104368 K212612 000
00843511104528 K212612 000
00843511104535 K212612 000
00843511105020 K212612 000
00843511105334 K212612 000
00843511105327 K212612 000
00843511105310 K212612 000
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00843511104801 K212612 000
00843511104795 K212612 000
00843511104788 K212612 000
00843511104771 K212612 000
00843511104931 K212612 000
00843511104948 K212612 000
00843511104320 K212612 000
00843511105402 K212612 000
00843511105396 K212612 000
00843511105389 K212612 000
00843511105372 K212612 000
00843511105365 K212612 000
00843511105358 K212612 000
00843511105341 K212612 000
00843511105044 K212612 000
00843511105013 K212612 000
00843511105006 K212612 000
00843511104993 K212612 000
00843511104986 K212612 000
00843511104979 K212612 000
00843511104962 K212612 000
00843511104955 K212612 000
00843511104764 K212612 000

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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