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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous surgical set with attachments
Regulation Description Manual percutaneous surgical set assembled in the abdomen.
Definition Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.
Product CodeOXT
Regulation Number 878.4805
Device Class 2

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