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U.S. Department of Health and Human Services

Product Classification

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Device cabinet, ethylene-oxide gas aerator
Regulation Description Ethylene oxide gas aerator cabinet.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFLI
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.6100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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