BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NITTO SURGICAL PAPER TAPE ST-310

    K Number: K853647 · Decision Sep 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    5
    Review Days
    16

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    Basic Information

    Device Name
    NITTO SURGICAL PAPER TAPE ST-310
    K Number
    K853647
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Nitto Denko America, Inc.
    Date Received
    September 3, 1985
    Decision Date
    September 19, 1985
    Product Code
    KGX
    Advisory Committee
    General Hospital
    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
    KGX Tape And Bandage, Adhesive

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    Other Clearances by Nitto Denko America, Inc.

    K Number Device Name
    K871441 ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE
    K853646 NITTO SURGICAL NON-WOVEN TAPE ST-320
    K853645 NITTO SURGICAL CLOTH TAPE ST-330
    K853644 NITTO SURGICAL PLASTIC TAPE ST-356