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510(k) FDA Premarket Notification K213222

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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
06934415066105 K213222 000
06934415066242 K213222 000
06934415066235 K213222 000
06934415066228 K213222 000
06934415066211 K213222 000
06934415066204 K213222 000
06934415066198 K213222 000
06934415066181 K213222 000
06934415066174 K213222 000
06934415066167 K213222 000
06934415066150 K213222 000
06934415066143 K213222 000
06934415066136 K213222 000
06934415066129 K213222 000
06934415066259 K213222 000
06934415066266 K213222 000
06934415066440 K213222 000
06934415066426 K213222 000
06934415066419 K213222 000
06934415066372 K213222 000
06934415066365 K213222 000
06934415066358 K213222 000
06934415066341 K213222 000
06934415066334 K213222 000
06934415066327 K213222 000
06934415066310 K213222 000
06934415066297 K213222 000
06934415066280 K213222 000
06934415066273 K213222 000
06934415066112 K213222 000

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Filename: fda.report/pmn_item.php

Line Number: 156

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Line: 156
Function: _error_handler


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