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U.S. Department of Health and Human Services

Product Classification
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Device injector, fluid, non-electrically powered
Regulation Description Nonelectrically powered fluid injector.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeKZE
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5430
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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