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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoilluminator, reprocessed
Definition Used intraocularly to provide light into the posterior of the eye during retinal surgery. Same as product code MPA, except this one is 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 CodeNKZ
Regulation Number 876.1500
Device Class 2

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