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

    NORTEC CONNECTING TUBE SET

    K Number: K911865 · Decision Nov 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    206
    Same Product Code
    26
    Applicant Total
    16
    Review Days
    189

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    Basic Information

    Device Name
    NORTEC CONNECTING TUBE SET
    K Number
    K911865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    North American Sterilization & Packaging Co.
    Date Received
    April 26, 1991
    Decision Date
    November 1, 1991
    Product Code
    GAZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAZ Tubing, Noninvasive

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    K925588 NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
    K925593 NORTEC STERILE WATER FOR DEVICE IRRIGATION
    K925161 NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
    K911784 NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
    K910691 NORTEC URETERAL STENT
    K903162 FLEXIBLE ENDOSCOPIC ELECTRODES
    K903156 CONTROL-TIP CYSTOSCOPIC ELECTRODES
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