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

    VITOP DRESSING

    K Number: K990974 · Decision Jun 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    270
    Applicant Total
    1
    Review Days
    78

    Basic Information

    Device Name
    VITOP DRESSING
    K Number
    K990974
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    WONDER & BIOENERGY HI-TECH AMERICA, INC.
    Date Received
    March 23, 1999
    Decision Date
    June 9, 1999
    Product Code
    EFQ
    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
    EFQ Gauze/Sponge, Internal

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