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U.S. Department of Health and Human Services

Product Classification

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Device plate, cranioplasty, preformed, alterable
Regulation Description Preformed alterable cranioplasty plate.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWO
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 882.5320
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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