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U.S. Department of Health and Human Services

Product Classification

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Device device, vibration threshold measurement
Review Panel Neurology
Product CodeLLN
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Not Classified Reason Enforcement Discretion
Submission Type 510(K) Exempt
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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