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U.S. Department of Health and Human Services

Product Classification

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Device unit, isolation, surgical
Regulation Description Air-handling apparatus for a surgical operating room.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeFRT
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control Devices (DHT4C)
Submission Type 510(k)
Regulation Number 878.5070
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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