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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 Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.1275
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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