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

    SAFEPETTE DISPENSER

    K Number: K890109 · Decision Feb 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    2
    Review Days
    44

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    Basic Information

    Device Name
    SAFEPETTE DISPENSER
    K Number
    K890109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Safe-Tec Clinical Products, Inc.
    Date Received
    January 10, 1989
    Decision Date
    February 23, 1989
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Safe-Tec Clinical Products, Inc.

    K Number Device Name
    K884623 SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE