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

    SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES

    K Number: K020318 · Decision Feb 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    369

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    Basic Information

    Device Name
    SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
    K Number
    K020318
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scivolutions, Inc.
    Date Received
    January 30, 2002
    Decision Date
    February 3, 2003
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Scivolutions, Inc.

    K Number Device Name
    K082208 DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER