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U.S. Department of Health and Human Services

Product Classification
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Device plate, cranioplasty, preformed, non-alterable
Regulation Description Preformed nonalterable cranioplasty plate.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXN
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5330
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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