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

    TLC SURGICAL DRAPES

    K Number: K951474 · Decision Aug 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    141

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    Basic Information

    Device Name
    TLC SURGICAL DRAPES
    K Number
    K951474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tlc Tech Lab Clothes, Inc.
    Date Received
    March 30, 1995
    Decision Date
    August 18, 1995
    Product Code
    KKY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

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    Other Clearances by Tlc Tech Lab Clothes, Inc.

    K Number Device Name
    K951623 TLC SURGICAL GOWNS