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510(k) FDA Premarket Notification P980052

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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
07613327626650 P980052 000
07613327626827 P980052 000
07613327626834 P980052 000
07613327626841 P980052 000
07613327626858 P980052 000
07613327626865 P980052 000
07613327626872 P980052 000
07613327626889 P980052 000
07613327626902 P980052 000
07613327626919 P980052 000
07613327626926 P980052 000
07613327626896 P980052 000
B0046120050 P980052 000
07613327626810 P980052 000
07613327626803 P980052 000
07613327626674 P980052 000
07613327626681 P980052 000
07613327626698 P980052 000
07613327626704 P980052 000
07613327626711 P980052 000
07613327626728 P980052 000
07613327626742 P980052 000
07613327626759 P980052 000
07613327626766 P980052 000
07613327626773 P980052 000
07613327626780 P980052 000
07613327626797 P980052 000
B0046120060 P980052 000
B0046120080 P980052 000
B0046120100 P980052 000
B0046523101 P980052 000
B0046123100 P980052 000
B0046123120 P980052 000
B0046123140 P980052 000
B0046123160 P980052 000
B0046520051 P980052 000
B0046523081 P980052 000
B0046520081 P980052 000
B0046520101 P980052 000
B0046520121 P980052 000
B0046520141 P980052 000
B0046123080 P980052 000
B0046123060 P980052 000
B0046120120 P980052 000
B0046520061 P980052 000
B004TYYNNNNM0 P980052 000
B0046520161 P980052 000
B0046120140 P980052 000
B0046523161 P980052 000
B0046523141 P980052 000
B0046523121 P980052 000
B0046120160 P980052 000
B0046523061 P980052 000
B004TYYNNNNLF0 P980052 004
B004TYYNNNNLM0 P980052 004
B004TYYNNNNRM0 P980052 004
B004TYYNNNNRF0 P980052 004
B004YYMMDDNNNNRM0 P980052 007
B004YYMMDDNNNNLM0 P980052 007
B004YYMMDDNNNNRF0 P980052 007
B004YYMMDDNNNNM0 P980052 007
B004YYMMDDNNNNLF0 P980052 007
07613327627800 P980052 012
07613327627787 P980052 012
07613327627770 P980052 012
07613327627763 P980052 012
07613327626605 P980052 012
07613327626575 P980052 012
07613327626568 P980052 012
07613327626551 P980052 012

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Severity: Notice

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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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