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U.S. Department of Health and Human Services

Product Classification
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Device methyl methacrylate for cranioplasty
Regulation Description Methyl methacrylate for cranioplasty.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXP
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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