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510(k) FDA Premarket Notification K230930

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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
00724995229016 K230930 000
00724995225377 K230930 000
00724995225360 K230930 000
00724995225353 K230930 000
00724995225346 K230930 000
00724995225339 K230930 000
00724995225322 K230930 000
00724995225315 K230930 000
00724995225308 K230930 000
00724995225292 K230930 000
00724995225285 K230930 000
00724995225278 K230930 000
00724995225261 K230930 000
00724995225254 K230930 000
00724995225247 K230930 000
00724995225230 K230930 000
00724995225223 K230930 000
00724995225216 K230930 000
00724995225384 K230930 000
00724995225391 K230930 000
00724995225407 K230930 000
00724995229009 K230930 000
00724995228484 K230930 000
00724995228477 K230930 000
00724995228460 K230930 000
00724995225537 K230930 000
00724995225520 K230930 000
00724995225513 K230930 000
00724995225506 K230930 000
00724995225490 K230930 000
00724995225483 K230930 000
00724995225476 K230930 000
00724995225469 K230930 000
00724995225452 K230930 000
00724995225445 K230930 000
00724995225438 K230930 000
00724995225421 K230930 000
00724995225414 K230930 000
00724995225209 K230930 000

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