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Can a PCCP be included as part of Special 510(k)?

  • 1.  Can a PCCP be included as part of Special 510(k)?

    This message was posted by a user wishing to remain anonymous
    Posted 22-Sep-2023 09:05
    This message was posted by a user wishing to remain anonymous

    As the title says, can a new (and initial) PCCP be included as part of a Special 510(k)?

    Reviewing the PCCP guidance, I get the impression that the answer is likely no, but I wanted to hear from members with experience in submitting a PCCP.



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