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U.S. Department of Health and Human Services

Product Classification

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Device two or more sterilant sterilizer
Regulation Description Ethylene oxide gas sterilizer.
Definition Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
Physical State sterilizer
Technical Method The sterilizer is a dual sterilant sterilizer using hydrogen peroxide and ozone as the sterilant
Target Area NA
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePJJ
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.6860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible