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U.S. Department of Health and Human Services

Product Classification

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Device needle, emergency airway
Regulation Description Emergency airway needle.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBWC
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 868.5090
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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