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510(k) FDA Premarket Notification K231087

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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
10841307128571 K231087 000
10841307128373 K231087 000
10841307128366 K231087 000
10841307128359 K231087 000
10841307128342 K231087 000
10841307128335 K231087 000
10841307128328 K231087 000
10841307128311 K231087 000
10841307128304 K231087 000
10841307128298 K231087 000
10841307128281 K231087 000
10841307128274 K231087 000
10841307128267 K231087 000
10841307128250 K231087 000
10841307128243 K231087 000
10841307128236 K231087 000
10841307128229 K231087 000
10841307128380 K231087 000
10841307128397 K231087 000
10841307128403 K231087 000
10841307128564 K231087 000
10841307128557 K231087 000
10841307128540 K231087 000
10841307128533 K231087 000
10841307128526 K231087 000
10841307128519 K231087 000
10841307128502 K231087 000
10841307128496 K231087 000
10841307128489 K231087 000
10841307128472 K231087 000
10841307128465 K231087 000
10841307128458 K231087 000
10841307128441 K231087 000
10841307128434 K231087 000
10841307128427 K231087 000
10841307128410 K231087 000
10841307128212 K231087 000

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Line: 156
Function: _error_handler


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