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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, tracheal, expandable
Regulation Description Tracheal prosthesis.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Anesthesiology
Product CodeJCT
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 878.3720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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