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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, peripheral nerve, implanted (pain relief)
Regulation Description Implanted peripheral nerve stimulator for pain relief.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZF
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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