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

    BONE-TEMNO/STERNUM-TEMNO

    K Number: K913306 · Decision Nov 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    99

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    Basic Information

    Device Name
    BONE-TEMNO/STERNUM-TEMNO
    K Number
    K913306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Proact, Ltd.
    Date Received
    July 25, 1991
    Decision Date
    November 1, 1991
    Product Code
    LWE
    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
    LWE Bone Marrow Collection/Transfusion Kit

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LWE), ordered by most recent decision date.

    JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

    FDA 510(k)
    FDA Class 2 ·Unknown

    BONE MARROW COLLECTION KIT AND STAND

    FDA 510(k)
    FDA Class 2 ·Unknown
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    Other Clearances by Proact, Ltd.

    K Number Device Name
    K941256 QUICK CORE II
    K926559 PROACT BIOPSY NEEDLE ENCHANCEMENTS
    K902320 BAUER FLEXI-TEMNO BIOPSY NEEDLE
    K902319 BAUER TEMNO BIOPSY NEEDLE