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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drills, burrs, trephines, and accessories (powered compound), reprocessed
Regulation Description Powered compound cranial drills, burrs, trephines, and their accessories.
Definition 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 CodeNLP
Regulation Number 882.4305
Device Class 2

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