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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laparoscopic bone anchor urethropexy instrument kit
Regulation Description Smooth or threaded metallic bone fixation fastener.
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 CodeNWN
Regulation Number 888.3040
Device Class 2