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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 Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery (DHT4B)
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
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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