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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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5740
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? Yes
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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