BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.

    K Number: K952470 · Decision Nov 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    7
    Applicant Total
    7
    Review Days
    186

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    Basic Information

    Device Name
    ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
    K Number
    K952470
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R-Group Intl.
    Date Received
    May 26, 1995
    Decision Date
    November 28, 1995
    Product Code
    GCD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCD Connector, Catheter

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