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

    SPETZLER TI 100 ANEURYSM CLIP

    K Number: K955064 · Decision Oct 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    8
    Review Days
    346

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    Basic Information

    Device Name
    SPETZLER TI 100 ANEURYSM CLIP
    K Number
    K955064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elekta Instruments, Inc.
    Date Received
    November 6, 1995
    Decision Date
    October 17, 1996
    Product Code
    HCH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HCH Clip, Aneurysm

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