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U.S. Department of Health and Human Services

Product Classification

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Device media, electroconductive
Regulation Description Electroconductive media.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGYB
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type 510(k)
Regulation Number 882.1275
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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