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U.S. Department of Health and Human Services

Product Classification

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Device filter, bacterial, breathing-circuit
Regulation Description Breathing circuit bacterial filter.
Regulation Medical Specialty Anesthesiology
Review Panel General Hospital
Product CodeCAH
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control Devices (DHT4C)
Submission Type 510(k)
Regulation Number 868.5260
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
Recognized Consensus Standards
Third Party Review
Accredited Persons
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