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U.S. Department of Health and Human Services

Product Classification

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Device electronic media, nausea
Definition Treatment of nausea and vomiting associated with morning sickness and motion sickness.
Review Panel General & Plastic Surgery
Product CodeNSS
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
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 Not Third Party Eligible
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