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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, biliary, reprocessed
Definition same as "FGE" except being reprocessed. 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 CodeNML
Regulation Number 876.5010
Device Class 2

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