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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device seminal fluid collection kit
Regulation Description Condom.
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 CodeOKW
Regulation Number 884.5300
Device Class 2

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