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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 Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type 510(k)
Regulation Number 882.5910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance Document for Dura Substitute Devices; Final Guidance for Industry
Third Party Review Not Third Party Eligible
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