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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device foley catheter kit (excludes hiv testing)
Regulation Description Urological catheter and accessories.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodePPB
Regulation Number 876.5130
Device Class 2

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