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

    CRYOBAG, MODEL CB

    K Number: K021702 · Decision Aug 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    4
    Review Days
    75

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    Basic Information

    Device Name
    CRYOBAG, MODEL CB
    K Number
    K021702
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Origen Biomedical, Inc.
    Date Received
    May 23, 2002
    Decision Date
    August 6, 2002
    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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    Other Clearances by Origen Biomedical, Inc.

    K Number Device Name
    K113869 ORIGEN REINFORCED DUAL LUMEN CATHETER
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