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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, pneumoperitoneum, spring loaded, reprocessed
Definition The "needle, penum...." is intended to insufflate the peritoneal cavity with gas during endoscopic procedures. This device is indiated 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 CodeNLX
Regulation Number 876.1500
Device Class 2

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