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U.S. Department of Health and Human Services

Product Classification

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Device apparatus, exhaust, surgical
Regulation Description Air-handling apparatus for a surgical operating room.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeFYD
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
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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