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U.S. Department of Health and Human Services

Product Classification

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Device apparatus, gas-scavenging
Regulation Description Gas-scavenging apparatus.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCBN
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type 510(k)
Regulation Number 868.5430
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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