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

    AMPU-PAK

    K Number: K860511 · Decision Aug 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    174

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    Basic Information

    Device Name
    AMPU-PAK
    K Number
    K860511
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Ammerman Medical Enterprises, Inc.
    Date Received
    February 11, 1986
    Decision Date
    August 4, 1986
    Product Code
    LPZ
    Advisory Committee
    Unknown
    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
    LPZ Container, Frozen Donor Tissue Storage

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