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

    CUTTER RESIFLEX FOLEY CATHETERS

    K Number: K781140 · Decision Sep 7, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    CUTTER RESIFLEX FOLEY CATHETERS
    K Number
    K781140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Cutler Laboratories, Inc.
    Date Received
    August 21, 1978
    Decision Date
    September 7, 1978
    Product Code
    DJC
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DJC Thin Layer Chromatography, Methamphetamine

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    Other Clearances by Cutler Laboratories, Inc.

    K Number Device Name
    K781785 I.V. SET WITH IN-LINE FILTER