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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 Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.4300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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