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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device submucosal injection agent
Regulation Description Endoscope and accessories.
Definition Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
Product CodePLL
Regulation Number 876.1500
Device Class 2

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