Device, Neurosurgical Fragmentation And Aspiration

Device Code: 3829

Product Code(s): LBK

Device Classification Information

Device Type ID3829
Device NameDevice, Neurosurgical Fragmentation And Aspiration
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLBK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3829
DeviceDevice, Neurosurgical Fragmentation And Aspiration
Product CodeLBK
TPLC Last Update: 2019-04-02 20:37:41

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.