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U.S. Department of Health and Human Services

Product Classification
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Device port & catheter, implanted, subcutaneous, intraventricular
Regulation Description Central nervous system fluid shunt and components.
Regulation Medical Specialty Neurology
Review Panel General Hospital
Product CodeLKG
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 882.5550
Device Class 2
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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