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U.S. Department of Health and Human Services

Product Classification

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Device catheter, ventricular
Regulation Description Ventricular catheter.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHCA
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 882.4100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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