BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AGEE-WRISTJACK PRE-DRILL KIT

    K Number: K942906 · Decision Dec 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    560
    Registration Numbers
    560
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    184

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    Basic Information

    Device Name
    AGEE-WRISTJACK PRE-DRILL KIT
    K Number
    K942906
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hand Biomechanics Lab, Inc.
    Date Received
    June 21, 1994
    Decision Date
    December 22, 1994
    Product Code
    HTW
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HTW Bit, Drill

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