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

    48 HOUR BIOLOGICAL INDICATORS SPORSTRIP

    K Number: K841709 · Decision Oct 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    3
    Review Days
    162

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    Basic Information

    Device Name
    48 HOUR BIOLOGICAL INDICATORS SPORSTRIP
    K Number
    K841709
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Skyland Scientific Services, Inc.
    Date Received
    April 23, 1984
    Decision Date
    October 2, 1984
    Product Code
    FRC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRC Indicator, Biological Sterilization Process

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    Other Clearances by Skyland Scientific Services, Inc.

    K Number Device Name
    K910417 EVIDENCE BIOLOGICAL INDICATOR
    K841583 SPORSTRIP