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U.S. Department of Health and Human Services

Product Classification
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Device strip, craniosynostosis, preformed
Regulation Description Preformed craniosynostosis strip.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXO
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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