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510(k) FDA Premarket Notification K241106

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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
06977357494421 K241106 000
06977357491208 K241106 000
06977357490744 K241106 000
06977357490652 K241106 000
06977357490416 K241106 000
06977357490393 K241106 000
06977357490386 K241106 000
06977357490355 K241106 000
06977357490348 K241106 000
06977357490225 K241106 000
06977357491215 K241106 000
06977357491628 K241106 000
06977357492533 K241106 000
06977357492397 K241106 000
06977357492380 K241106 000
06977357492076 K241106 000
06977357491901 K241106 000
06977357491895 K241106 000
06977357491741 K241106 000
06977357491642 K241106 000
06977357491635 K241106 000
06977357490126 K241106 000

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