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U.S. Department of Health and Human Services

Product Classification

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Device orthosis, cranial
Regulation Description Cranial orthosis.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeMVA
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5970
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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