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

    DOUBLE SEAL TUBEGUAZE STERILE BANDAGE

    K Number: K813308 · Decision Dec 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    DOUBLE SEAL TUBEGUAZE STERILE BANDAGE
    K Number
    K813308
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Scholl, Inc.
    Date Received
    November 23, 1981
    Decision Date
    December 29, 1981
    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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