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

    SIMPEX INC. SURGICAL DRESSING

    K Number: K913794 · Decision Nov 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    SIMPEX INC. SURGICAL DRESSING
    K Number
    K913794
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Simpex, Inc.
    Date Received
    August 23, 1991
    Decision Date
    November 20, 1991
    Product Code
    GDY
    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
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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    Other Clearances by Simpex, Inc.

    K Number Device Name
    K920174 EASY TOUCH LATEX EAM GLOVES
    K913793 SIMPEX INC. ORAL AND RECTAL THERMOMETERS
    K911505 FIXATION WIRE
    K911452 FIXATION PIN