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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blade, keratome, reprocessed
Definition Blade for keratome to make flap in cornea for LASIK refractive surgery. Same as previously cleared blade for keratomes, product codes HMY and HNO, except this 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 CodeNKY
Regulation Number 886.4370
Device Class 1

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