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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, flexible suction coagulator, reprocessed
Definition The "electorde, flexible suction coagulator, reprocessed" is intended to be used endoscopically to provide simultaneous suction of fluids and coagulation of tissue. This device is indicated for reuse/reprocessing. 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 CodeNLV
Regulation Number 876.4300
Device Class 2

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