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

    CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH

    K Number: K914316 · Decision Dec 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    13
    Review Days
    89

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    Basic Information

    Device Name
    CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH
    K Number
    K914316
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Medi-Flex Hospital Products, Inc.
    Date Received
    September 26, 1991
    Decision Date
    December 24, 1991
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    K934790 SEPP ADHESIVE REMOVER
    K920399 COMPOUND BENZOIN TINCTURE USP FREPP
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