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

    CATHETER CARE KIT REORDER 7940&7941

    K Number: K791888 · Decision Oct 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    CATHETER CARE KIT REORDER 7940&7941
    K Number
    K791888
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Ascep, Inc.
    Date Received
    September 11, 1979
    Decision Date
    October 17, 1979
    Product Code
    EFQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EFQ Gauze/Sponge, Internal

    Similar 510(k) Clearances

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    SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S

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    VITOP DRESSING

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    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

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    CROSSTEX NON-WOVEN SPONGES

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    FDA Unclassified ·Unknown

    GAUZE, SPONGES, CAT # 11-003

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    FDA Unclassified ·Unknown
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    Other Clearances by Ascep, Inc.

    K Number Device Name
    K830219 VARIOUS INSTRUMENTS & INSTRUMENT TRAYS
    K822893 G.E.V. DISPOSABLE SCALPELS
    K810004 STERILE DISPOSABLE INSTRUMENT TRAYS
    K802726 INSTRUMENTS NONSTERILE & STERILE
    K791886 I.V. CARE KIT
    K791885 I.V. START SET
    K791887 CENTRAL VENOUS CATHETER DRESSING TRAY
    K791889 SUTURE REMOVAL TRAY, REORDER 7950&7951