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510(k) FDA Premarket Notification K231037

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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
07630030855344 K231037 000
07630345774163 K231037 000
07630345774170 K231037 000
07630345774187 K231037 000
07630345774194 K231037 000
07630345774200 K231037 000
07630345774217 K231037 000
07630345774224 K231037 000
07630345774231 K231037 000
07630345774156 K231037 000
07630345774149 K231037 000
07630345774132 K231037 000
07630030855306 K231037 000
07630345774064 K231037 000
07630345774071 K231037 000
07630345774088 K231037 000
07630345774095 K231037 000
07630345774101 K231037 000
07630345774118 K231037 000
07630345774125 K231037 000
07630345774248 K231037 000
07630345774255 K231037 000
07630345774378 K231037 000
07630345774385 K231037 000
07630345774392 K231037 000
07630345774408 K231037 000
07630345774415 K231037 000
07630345774422 K231037 000
07630345774439 K231037 000
07630345774446 K231037 000
07630345774361 K231037 000
07630345774354 K231037 000
07630345774347 K231037 000
07630345774262 K231037 000
07630345774279 K231037 000
07630345774286 K231037 000
07630345774293 K231037 000
07630345774309 K231037 000
07630345774316 K231037 000
07630345774323 K231037 000
07630345774330 K231037 000
07630345774453 K231037 000

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