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U.S. Department of Health and Human Services

Product Classification

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Device pump, infusion, insulin
Regulation Description Infusion pump.
Regulation Medical Specialty General Hospital
Review Panel Clinical Chemistry
Product CodeLZG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Chemistry and Toxicology Devices (DCTD)
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
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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