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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device port, protector/cushion
Regulation Description Subcutaneous, implanted, intravascular infusion port and catheter.
Definition Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
Product CodeOBK
Regulation Number 880.5965
Device Class 2

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