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

    ACRA-CUT

    K Number: K944311 · Decision Nov 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    9
    Applicant Total
    8
    Review Days
    77

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    Basic Information

    Device Name
    ACRA-CUT
    K Number
    K944311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4150
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acra Cut, Inc.
    Date Received
    September 2, 1994
    Decision Date
    November 18, 1994
    Product Code
    HBO
    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
    HBO Clip, Scalp

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    Other Clearances by Acra Cut, Inc.

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    K910225 BONE PAD REMOVER
    K910226 DURAL DISSECTORS
    K892866 AUTOMATIC CRANIAL DRILL (PERFORATOR)
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