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510(k) FDA Premarket Notification K241873

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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
00889024679313 K241873 000
00889024678903 K241873 000
00889024678897 K241873 000
00889024678880 K241873 000
00889024678873 K241873 000
00889024678866 K241873 000
00889024678859 K241873 000
00889024678842 K241873 000
00889024678835 K241873 000
00889024678828 K241873 000
00889024678811 K241873 000
00889024678804 K241873 000
00889024678798 K241873 000
00889024678781 K241873 000
00889024678774 K241873 000
00889024678767 K241873 000
00889024678750 K241873 000
00889024678743 K241873 000
00889024678910 K241873 000
00889024678927 K241873 000
00889024679306 K241873 000
00889024679290 K241873 000
00889024679283 K241873 000
00889024679245 K241873 000
00889024679238 K241873 000
00889024679221 K241873 000
00889024679207 K241873 000
00889024679191 K241873 000
00889024679184 K241873 000
00889024679177 K241873 000
00889024679160 K241873 000
00889024679153 K241873 000
00889024679146 K241873 000
00889024679139 K241873 000
00889024679122 K241873 000
00889024679115 K241873 000
00889024678934 K241873 000
00889024678736 K241873 000

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Filename: fda.report/pmn_item.php

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Line: 156
Function: _error_handler


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