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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, tracheotomy care
Regulation Description Tracheostomy tube and tube cuff.
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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeNXA
Regulation Number 868.5800
Device Class 2

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