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U.S. Department of Health and Human Services

Product Classification

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Device set, oral administration
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General Hospital
Product CodeLEY
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 876.5980
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 Not Third Party Eligible
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