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

    L.T.C. REPLACEMENT GASTROSTOMY TUBE

    K Number: K896621 · Decision Mar 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    112

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    Basic Information

    Device Name
    L.T.C. REPLACEMENT GASTROSTOMY TUBE
    K Number
    K896621
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Intl. Medical Marketing, Inc.
    Date Received
    November 21, 1989
    Decision Date
    March 13, 1990
    Product Code
    KCQ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCQ Tube Impression And Matrix

    Other Clearances by Intl. Medical Marketing, Inc.

    K Number Device Name
    K897181 L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
    K895824 L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET
    K895957 L.T.C. 1000 URINARY DRAINAGE BAG
    K895616 L.T.C. FEEDING TUBE