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

    ALPHA MICRON 20/40 MICROAGGREGATE FILTER

    K Number: K970225 · Decision Feb 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    35
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    ALPHA MICRON 20/40 MICROAGGREGATE FILTER
    K Number
    K970225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha Therapeutic Corp.
    Date Received
    January 17, 1997
    Decision Date
    February 14, 1997
    Product Code
    CAK
    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
    CAK Microfilter, Blood Transfusion

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