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

    SURGEX SURGICAL SPONGE

    K Number: K761034 · Decision Jan 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    10
    Review Days
    51

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    Basic Information

    Device Name
    SURGEX SURGICAL SPONGE
    K Number
    K761034
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Convertors
    Date Received
    November 15, 1976
    Decision Date
    January 5, 1977
    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 Convertors

    K Number Device Name
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    K781959 SURGICAL GOWNS, SHEETS
    K781534 SURG-O-PAK PREP PAD
    K781099 SURGICAL GOWNS AND DRAPES
    K780169 MASK, SURGICAL
    K771929 PEDIATRICS GOWN
    K770933 BIO-SHIELD CSR WRAP
    K770346 ORTHOPEDIC STOCKINETTE