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

    MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION

    K Number: K932743 · Decision Sep 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    9
    Review Days
    94

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    Basic Information

    Device Name
    MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION
    K Number
    K932743
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scott Health Care
    Date Received
    June 8, 1993
    Decision Date
    September 10, 1993
    Product Code
    KGX
    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
    KGX Tape And Bandage, Adhesive

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    Other Clearances by Scott Health Care

    K Number Device Name
    K954275 MEPORE PLUS (9X15CM)
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    K945206 ALLDRESS MULTI LAYERED WOUND DRESSING
    K905439 HYPERGEL PROTECTIVE WOUND GEL
    K910857 ALLDRESS MULTI LAYERED WOUND DRESSING
    K905438 NORMLGEL PROTECTIVE WOUND GEL
    K900421 PROMISE ABSORBENT PROTECTIVE PAD
    K897142 MESALT STERILE DRESSING