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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 Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.5045
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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