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U.S. Department of Health and Human Services

Product Classification

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Device device, aversive conditioning
Regulation Description Aversive conditioning device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHCB
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 882.5235
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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