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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device disposable joint aspiration/injection kit
Regulation Description Manual surgical instrument for general use.
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 CodePPP
Regulation Number 878.4800
Device Class 1

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