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

    MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES

    K Number: K915821 · Decision May 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    5
    Review Days
    151

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    Basic Information

    Device Name
    MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES
    K Number
    K915821
    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
    December 30, 1991
    Decision Date
    May 29, 1992
    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.

    K Number Device Name
    K931042 MOORE SECURE CAP
    K915822 MULTIPLE DRESSING, STERILE NONADDHERENT PADS
    K914937 STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES
    K914071 MULTIPLE BURN DRESSING