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U.S. Department of Health and Human Services

Product Classification

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Device trocar, tracheal, laryngeal, sinus, reprocessed
Regulation Description Ear, nose, and throat manual surgical instrument.
Definition Same as kbg, kab, and kci but need one code for reprocessing.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeNLB
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(k)
Regulation Number 874.4420
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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