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

    PROCEL(TM) DERMALINER GLOVE

    K Number: K931094 · Decision Feb 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    801
    Registration Numbers
    801
    Same Product Code
    55
    Applicant Total
    163
    Review Days
    348

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    Basic Information

    Device Name
    PROCEL(TM) DERMALINER GLOVE
    K Number
    K931094
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    March 3, 1993
    Decision Date
    February 14, 1994
    Product Code
    LYU
    Advisory Committee
    General, Plastic Surgery
    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
    LYU Accessory, Surgical Apparel

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