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U.S. Department of Health and Human Services

Product Classification

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Device device, germicidal, ultraviolet
Regulation Description Medical ultraviolet air purifier.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeMKB
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.6500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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