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510(k) FDA Premarket Notification K212715

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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
00840283400179 K212715 000
00840283400087 K212715 000
00840283400070 K212715 000
00840283400063 K212715 000
00840283400056 K212715 000
00840283400049 K212715 000
00840283400032 K212715 000
00840283400025 K212715 000
00840283400278 K212715 000
00840283400261 K212715 000
00840283400254 K212715 000
00840283400292 K212715 000
00840283400285 K212715 000
00840283400247 K212715 000
00840283400193 K212715 000
00840283400162 K212715 000
00840283400155 K212715 000
00840283400148 K212715 000
00840283400131 K212715 000
00840283400124 K212715 000
00840283400117 K212715 000
00840283400100 K212715 000
00840283400094 K212715 000
00840283400230 K212715 000
00840283400223 K212715 000
00840283400216 K212715 000
00840283400209 K212715 000
00840283400308 K212715 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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