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U.S. Department of Health and Human Services

Product Classification

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Device tube, tracheal, reprocessed
Regulation Description Tracheal tube.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeNMA
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 868.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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