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U.S. Department of Health and Human Services

Product Classification

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Device filter, bacterial, breathing-circuit
Regulation Medical Specialty Anesthesiology
Review Panel General Hospital
Product CodeCAH
Premarket Review Infection Control and Plastic Surgery Devices (DHT4B)
Infection Control and Plastic Surgery Devices (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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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