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

    AUTOMATIC TEFLON INJECTION SYRINGE

    K Number: K810284 · Decision Mar 11, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    37

    Basic Information

    Device Name
    AUTOMATIC TEFLON INJECTION SYRINGE
    K Number
    K810284
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5220
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    R. WOLF MEDICAL INSTRUMENTS CORP.
    Date Received
    February 2, 1981
    Decision Date
    March 11, 1981
    Product Code
    KCP
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCP Syringe, Ent

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