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

    GAUZE SPONGE STERILE SPONGE

    K Number: K831183 · Decision Jun 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    GAUZE SPONGE STERILE SPONGE
    K Number
    K831183
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Den Med, Inc.
    Date Received
    April 11, 1983
    Decision Date
    June 8, 1983
    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

    Similar 510(k) Clearances

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    Other Clearances by Den Med, Inc.

    K Number Device Name
    K831182 GAUZE SPONGE-NON-STERILE SPONGE