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

    SURGICAL EYE SPONGE

    K Number: K790467 · Decision Mar 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    SURGICAL EYE SPONGE
    K Number
    K790467
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Medtech Intl., Inc.
    Date Received
    March 5, 1979
    Decision Date
    March 26, 1979
    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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    Other Clearances by Medtech Intl., Inc.

    K Number Device Name
    K920876 CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER
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    K791462 HYPERDERMIC NEEDLE WITH SENSOR #514
    K790389 GAUZE & COTTON SPONGES
    K781157 STIMULATOR, NERVE, TRANSCUTANEOUS