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U.S. Department of Health and Human Services

Product Classification

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Device sterilizer, ethylene-oxide gas
Regulation Description Ethylene oxide gas sterilizer.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFLF
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 880.6860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons