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U.S. Department of Health and Human Services

Product Classification
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Device decontamination systems for n95 respirators
Definition Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.
Physical State Sterilization or disinfection system
Technical Method Sterilization or disinfection
Target Area Previously used N95 or N95-equivalent respirators
Review Panel General Hospital
Product CodeQKY
Premarket Review Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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