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U.S. Department of Health and Human Services

Product Classification

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Device drills, burrs, trephines and accessories (manual), reprocessed
Regulation Description Manual cranial drills, burrs, trephines, and their accessories
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNLO
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 882.4300
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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