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

    WELLS LAMONT HANDAGES/MED WRAP DRESSINGS

    K Number: K925937 · Decision Aug 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    4
    Review Days
    258

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    Basic Information

    Device Name
    WELLS LAMONT HANDAGES/MED WRAP DRESSINGS
    K Number
    K925937
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wells Lamont Corp.
    Date Received
    November 24, 1992
    Decision Date
    August 9, 1993
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

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    Other Clearances by Wells Lamont Corp.

    K Number Device Name
    K944763 CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER
    K940274 NYLON LINER GLOVES
    K922407 WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS