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U.S. Department of Health and Human Services

Product Classification
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Device dura substitute
Regulation Description Dura substitute.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXQ
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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