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510(k) FDA Premarket Notification K231275

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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
10840642171150 K231275 000
10840642171006 K231275 000
10840642170993 K231275 000
10840642170986 K231275 000
10840642170979 K231275 000
10840642170962 K231275 000
10840642170955 K231275 000
10840642170948 K231275 000
10840642170931 K231275 000
10840642170924 K231275 000
10840642170917 K231275 000
10840642170900 K231275 000
10840642170894 K231275 000
10840642171013 K231275 000
10840642171020 K231275 000
10840642171143 K231275 000
10840642171136 K231275 000
10840642171129 K231275 000
10840642171112 K231275 000
10840642171105 K231275 000
10840642171099 K231275 000
10840642171082 K231275 000
10840642171075 K231275 000
10840642171068 K231275 000
10840642171051 K231275 000
10840642171044 K231275 000
10840642171037 K231275 000
10840642170887 K231275 000

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Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
Function: _error_handler


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