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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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 874.4420
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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