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510(k) FDA Premarket Notification K221047

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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
B521114600030 K221047 000
B52111036420 K221047 000
B5211107120 K221047 000
B521114001240 K221047 000
B52111400445200 K221047 000
B52111400445260 K221047 000
B521114300010 K221047 000
B521114301010 K221047 000
B52111430301240 K221047 000
B5211143090 K221047 000
B521114310010 K221047 000
B521114310020 K221047 000
B521114310030 K221047 000
B5211143150 K221047 000
B521114600010 K221047 000
B521114600020 K221047 000
B52111036110 K221047 000

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