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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device emergency obstetrical kit
Regulation Description Obstetric-gynecologic general manual instrument.
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 CodeOKU
Regulation Number 884.4520
Device Class 1