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510(k) FDA Premarket Notification P190016

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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
00840128600009 P190016 000
00840128600016 P190016 000
00840128600023 P190016 000
00840128600030 P190016 000
00840128600047 P190016 000
20840128600058 P190016 000
20840128600072 P190016 000
20840128600089 P190016 000
20840128600096 P190016 000
20840128600102 P190016 000
00840128600160 P190016 000
20840128600201 P190016 000
00840128600153 P190016 000
00840128600146 P190016 000
00840128600139 P190016 000
20840128600126 P190016 000
20840128600119 P190016 000
00840128600009 P190016 002
00840128600016 P190016 002
00840128600023 P190016 002
00840128600030 P190016 002
20840128600058 P190016 002
20840128600201 P190016 002
00885556817674 P190016 007
00885556817742 P190016 007
00885556817759 P190016 007
00885556817766 P190016 007
00885556817773 P190016 007
00885556817780 P190016 007
00885556817797 P190016 007
20885556817685 P190016 007
20885556817692 P190016 007
20885556817708 P190016 007
20885556817715 P190016 007
20885556817722 P190016 007
20885556817739 P190016 007
00885556817667 P190016 007

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Function: _error_handler


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