Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

Device Code: 3743

Product Code(s): MYU

Device Classification Information

Device Type ID3743
Device NameAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Regulation DescriptionMethyl Methacrylate For Cranioplasty.
Regulation Medical SpecialtyNeurology
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)
CFR Regulation Number882.5300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMYU
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3743
DeviceAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Product CodeMYU
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMethyl Methacrylate For Cranioplasty.
CFR Regulation Number882.5300 [🔎]
TPLC Last Update: 2019-04-02 20:35:51

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