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510(k) FDA Premarket Notification K223474

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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
08800108699173 K223474 000
08800108699180 K223474 000
08800108699135 K223474 000
08800108699128 K223474 000
08800108699098 K223474 000
08800108699081 K223474 000
08800108699074 K223474 000
08800108699029 K223474 000
08800108699012 K223474 000
08800108699005 K223474 000
08800108698992 K223474 000
08800108698985 K223474 000
08800108698978 K223474 000
08800108698961 K223474 000
08800108699197 K223474 000
08800108699203 K223474 000
08800108699111 K223474 000
08800108698954 K223474 000
08800108698893 K223474 000
08800108699104 K223474 000
08800108698909 K223474 000
08800108699326 K223474 000
08800108699319 K223474 000
08800108699302 K223474 000
08800108699296 K223474 000
08800108699241 K223474 000
08800108699234 K223474 000
08800108699227 K223474 000
08800108699210 K223474 000
08800108698916 K223474 000

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Line Number: 156

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Line: 156
Function: _error_handler


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