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U.S. Department of Health and Human Services

Product Classification
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Device drainage catheter with antibiotic
Regulation Description Powered suction pump.
Definition A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.
Physical State A tubular drain made from silicone or similar material and is coated with a silver containing material
Technical Method Gravity drainage or attached to a suction pump
Target Area Normally any body cavity following surgery
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOEI
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4780
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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