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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tether accessory for use in the gastrointestinal tract
Definition A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract.
Product CodeQUN
Regulation Number 876.1305
Device Class 2

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