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U.S. Department of Health and Human Services

Product Classification

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Device tube tracheostomy and tube cuff
Regulation Description Tracheostomy tube and tube cuff.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeJOH
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 868.5800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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