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U.S. Department of Health and Human Services

Product Classification

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Device cleaner, air, medical recirculating
Regulation Description Medical recirculating air cleaner.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFRF
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.5045
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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