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gptkb:Section_510(k)_(Premarket_Notification)
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device description
|
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gptkb:510(k)_premarket_notification_for_medical_devices
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performance data
|
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gptkb:Section_510(k)_(Premarket_Notification)
|
labeling
|
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gptkb:FDA_510(k)
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intended use
|
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gptkb:510(k)_clearance_in_US
|
intended use
|
|
gptkb:FDA_510(k)
|
device description
|
|
gptkb:Section_510(k)_(Premarket_Notification)
|
safety and effectiveness information
|
|
gptkb:FDA_510(k)
|
performance data
|
|
gptkb:510(k)_clearance_in_US
|
substantial equivalence comparison
|
|
gptkb:Premarket_Approval_(PMA)_for_medical_devices
|
device description
|
|
gptkb:510(k)_clearance_in_US
|
device description
|
|
gptkb:510(k)_clearance_in_US
|
proposed indications for use
|
|
gptkb:Premarket_Approval_(PMA)_for_medical_devices
|
manufacturing information
|
|
gptkb:Premarket_Approval_(PMA)_for_medical_devices
|
proposed indications for use
|
|
gptkb:FDA_510(k)
|
substantial equivalence comparison
|
|
gptkb:Premarket_Approval_(PMA)_for_medical_devices
|
labeling
|
|
gptkb:FDA_510(k)
|
labeling
|
|
gptkb:510(k)_premarket_notification_for_medical_devices
|
device description
|
|
gptkb:510(k)_premarket_notification_for_medical_devices
|
substantial equivalence comparison
|
|
gptkb:Section_510(k)_(Premarket_Notification)
|
performance data
|