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

    ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK

    K Number: K884615 · Decision Jan 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    3
    Review Days
    76

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    Basic Information

    Device Name
    ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK
    K Number
    K884615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pymah Corp., Ati Div.
    Date Received
    November 4, 1988
    Decision Date
    January 19, 1989
    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 Pymah Corp., Ati Div.

    K Number Device Name
    K895704 ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE
    K884767 ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK