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

    IMBIBE BONE MARROW ASPIRATION SYRINGE

    K Number: K023074 · Decision Mar 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    23
    Review Days
    176

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    Basic Information

    Device Name
    IMBIBE BONE MARROW ASPIRATION SYRINGE
    K Number
    K023074
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthovita, Inc.
    Date Received
    September 16, 2002
    Decision Date
    March 11, 2003
    Product Code
    FMF
    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
    FMF Syringe, Piston

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