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

    WYMAN SUTURE WASHER

    K Number: K910186 · Decision Jul 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    262
    Registration Numbers
    262
    Same Product Code
    88
    Applicant Total
    43
    Review Days
    191

    Basic Information

    Device Name
    WYMAN SUTURE WASHER
    K Number
    K910186
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    ACUMED, INC.
    Date Received
    January 15, 1991
    Decision Date
    July 25, 1991
    Product Code
    HTN
    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
    HTN Washer, Bolt Nut

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