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U.S. Department of Health and Human Services

Product Classification

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Device tube, tracheal/bronchial, differential ventilation (w/wo connector)
Regulation Description Tracheal/bronchial differential ventilation tube.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCBI
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 868.5740
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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