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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic morcellator gastroenterology
Regulation Description Hysteroscope and accessories.
Definition For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)
Product CodePTE
Regulation Number 884.1690
Device Class 2

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