BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STRUNG TELFA NON-ADHERENT SPONGE

    K Number: K904514 · Decision Mar 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    23
    Applicant Total
    14
    Review Days
    176

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    Basic Information

    Device Name
    STRUNG TELFA NON-ADHERENT SPONGE
    K Number
    K904514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4700
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    American Silk Sutures, Inc.
    Date Received
    October 2, 1990
    Decision Date
    March 27, 1991
    Product Code
    HBA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBA Neurosurgical Paddie

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    K872809 GAUZE CHERRY SPONGE
    K872808 CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8
    K872806 STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG
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