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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 Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery (DHT4B)
Submission Type 510(k)
Regulation Number 880.6100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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