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

    MEDI-SURE, MEDI-SORB

    K Number: K897180 · Decision Aug 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    1
    Review Days
    216

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    Basic Information

    Device Name
    MEDI-SURE, MEDI-SORB
    K Number
    K897180
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Gulf Coast Medical, Inc.
    Date Received
    December 28, 1989
    Decision Date
    August 1, 1990
    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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