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510(k) FDA Premarket Notification K241395

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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
00851979007671 K241395 000
00851979007596 K241395 000
00851979007572 K241395 000
00851979007565 K241395 000
00851979007558 K241395 000
00851979007527 K241395 000
00851979007510 K241395 000
00851979007503 K241395 000
00851979007442 K241395 000
00851979007435 K241395 000
00851979007312 K241395 000
00851979007619 K241395 000
00851979007015 K241395 000
00851979007022 K241395 000
00851979007664 K241395 000
00851979007480 K241395 000
00851979007466 K241395 000
00851979007428 K241395 000
00851979007404 K241395 000
00851979007381 K241395 000
00851979007367 K241395 000
00851979007336 K241395 000
00851979007046 K241395 000
00851979007039 K241395 000
00851979007305 K241395 000

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