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U.S. Department of Health and Human Services

Product Classification

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Device accessory,barium sulfate,methyl methacrylate for cranioplasty
Regulation Description Methyl methacrylate for cranioplasty.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeMYU
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type 510(k)
Regulation Number 882.5300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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