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U.S. Department of Health and Human Services

Product Classification

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Device sterilizer, steam
Regulation Description Steam sterilizer.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFLE
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.6880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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