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510(k) FDA Premarket Notification K241131

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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
09120046326764 K241131 000
09120046325132 K241131 000
09120046322575 K241131 000
09120046322568 K241131 000
09120046322551 K241131 000
09120046322544 K241131 000
09120046322537 K241131 000
09120046322513 K241131 000
09120046322506 K241131 000
09120046322490 K241131 000
09120046322483 K241131 000
09120046322476 K241131 000
09120046322452 K241131 000
09120046322445 K241131 000
09120046322438 K241131 000
09120046322421 K241131 000
09120046325149 K241131 000
09120046325156 K241131 000
09120046325163 K241131 000
09120046326757 K241131 000
09120046326740 K241131 000
09120046326733 K241131 000
09120046326726 K241131 000
09120046326719 K241131 000
09120046326702 K241131 000
09120046326696 K241131 000
09120046326689 K241131 000
09120046326672 K241131 000
09120046326658 K241131 000
09120046326641 K241131 000
09120046326634 K241131 000
09120046326627 K241131 000
09120046326610 K241131 000
09120046325170 K241131 000
09120046322414 K241131 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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