BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PARAMETRIC STERILITY RELEASE OF AUTO

    K Number: K830741 · Decision Aug 11, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    7
    Review Days
    156

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    Basic Information

    Device Name
    PARAMETRIC STERILITY RELEASE OF AUTO
    K Number
    K830741
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    United Surgical Corp.
    Date Received
    March 8, 1983
    Decision Date
    August 11, 1983
    Product Code
    GAG
    Advisory Committee
    General Hospital
    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
    GAG Stapler, Surgical

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