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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 Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep 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
Guidance Document
Third Party Review Not Third Party Eligible
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