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510(k) FDA Premarket Notification K250444

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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
M684NEXSCL001 K250444 000
M684NEXHCL071 K250444 000
M684NEXHCL081 K250444 000
M684NEXHCL091 K250444 000
M684NEXHCL101 K250444 000
M684NEXHCL111 K250444 000
M684NEXHCL121 K250444 000
M684NEXSNC001 K250444 000
M684NEXSNC011 K250444 000
M684NEXSNC021 K250444 000
M684NEXSNC031 K250444 000
M684NEXSNC041 K250444 000
M684NEXSNC051 K250444 000
M684NEXSNC061 K250444 000
M684NEXSNC071 K250444 000
M684NEXSNC081 K250444 000
M684NEXSNC091 K250444 000
M684NEXSNC101 K250444 000
M684NEXHCL061 K250444 000
M684NEXHCL051 K250444 000
M684NEXSCL011 K250444 000
M684NEXSCL021 K250444 000
M684NEXSCL031 K250444 000
M684NEXSCL041 K250444 000
M684NEXSCL051 K250444 000
M684NEXSCL061 K250444 000
M684NEXSCL071 K250444 000
M684NEXSCL081 K250444 000
M684NEXSCL091 K250444 000
M684NEXSCL101 K250444 000
M684NEXSCL111 K250444 000
M684NEXSCL121 K250444 000
M684NEXHCL001 K250444 000
M684NEXHCL011 K250444 000
M684NEXHCL021 K250444 000
M684NEXHCL031 K250444 000
M684NEXHCL041 K250444 000
M684NEXSNC111 K250444 000
M684NEXSNC121 K250444 000
M684NEXHNC001 K250444 000
M684NEXBCH071 K250444 000
M684NEXBCH081 K250444 000
M684NEXBCH091 K250444 000
M684NEXBCH101 K250444 000
M684NEXBCH111 K250444 000
M684NEXBCH121 K250444 000
M684NEXTNSGA1 K250444 000
M684NEXTNSGB1 K250444 000
M684NEXTNSGC1 K250444 000
M684NEXTNSGD1 K250444 000
M684NEXTNSGE1 K250444 000
M684NEXTNSGF1 K250444 000
M684NEXTNHGA1 K250444 000
M684NEXTNHGB1 K250444 000
M684NEXTNHGC1 K250444 000
M684NEXTNHGD1 K250444 000
M684NEXTNHGE1 K250444 000
M684NEXBCH061 K250444 000
M684NEXBCH051 K250444 000
M684NEXHNC011 K250444 000
M684NEXHNC021 K250444 000
M684NEXHNC031 K250444 000
M684NEXHNC041 K250444 000
M684NEXHNC051 K250444 000
M684NEXHNC061 K250444 000
M684NEXHNC071 K250444 000
M684NEXHNC081 K250444 000
M684NEXHNC091 K250444 000
M684NEXHNC101 K250444 000
M684NEXHNC111 K250444 000
M684NEXHNC121 K250444 000
M684NEXBCH001 K250444 000
M684NEXBCH011 K250444 000
M684NEXBCH021 K250444 000
M684NEXBCH031 K250444 000
M684NEXBCH041 K250444 000
M684NEXTNHGF1 K250444 000

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Function: _error_handler


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