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U.S. Department of Health and Human Services

Product Classification

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Device tube, bronchial (w/wo connector)
Regulation Description Bronchial tube.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBTS
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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