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U.S. Department of Health and Human Services

Product Classification

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Device holder, head, neurosurgical (skull clamp)
Regulation Description Neurosurgical head holder (skull clamp).
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHBL
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 882.4460
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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