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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bur, ent, diamond coated, single use, reprocessed
Definition ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. 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 CodeNLZ
Regulation Number 874.4140
Device Class 1

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