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

    STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES

    K Number: K914937 · Decision Dec 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    585
    Registration Numbers
    585
    Same Product Code
    67
    Applicant Total
    5
    Review Days
    30

    Basic Information

    Device Name
    STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES
    K Number
    K914937
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    KERMA MEDICAL PRODUCTS, INC.
    Date Received
    November 4, 1991
    Decision Date
    December 4, 1991
    Product Code
    NAB
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

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    Other Clearances by KERMA MEDICAL PRODUCTS, INC.

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