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

    SPORTROL RAPID STERILITY INDICATOR

    K Number: K962649 · Decision Sep 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    445

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    Basic Information

    Device Name
    SPORTROL RAPID STERILITY INDICATOR
    K Number
    K962649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    North American Science Assoc., Inc.
    Date Received
    July 8, 1996
    Decision Date
    September 26, 1997
    Product Code
    MTC
    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
    MTC Indicator, Chemical, Enzymatic, Sterilization Process

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    K132291 NAMSA CHEMICAL PROCESS
    K113221 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
    K113302 NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
    K983451 CHALLENGE TEST PACK