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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 Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostics (DHT5A)
Submission Type 510(k)
Regulation Number 882.4460
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
Accredited Persons
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