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U.S. Department of Health and Human Services

Product Classification

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Device pump, infusion, analytical sampling
Regulation Description Infusion pump.
Regulation Medical Specialty General Hospital
Review Panel Clinical Chemistry
Product CodeLZF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 880.5725
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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