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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prostate seeding kit
Regulation Description Radionuclide brachytherapy source.
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 CodeOIN
Regulation Number 892.5730
Device Class 2

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