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U.S. Department of Health and Human Services

Product Classification
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Device device, peritoneal access, subcutaneous, implanted
Review Panel General Hospital
Product CodeLMQ
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type Contact ODE
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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