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U.S. Department of Health and Human Services

Product Classification

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Device applier, aneurysm clip
Regulation Description Aneurysm clip applier.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHCI
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 882.4175
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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