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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLB
Regulation Number 874.4420
Device Class 1

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