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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nasal endotracheal tube holder kit
Regulation Description Tracheal tube fixation device.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOGI
Regulation Number 868.5770
Device Class 1