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U.S. Department of Health and Human Services

Product Classification

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Device neurological stereotaxic instrument
Regulation Description Stereotaxic instrument.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHAW
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 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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