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

    PHARMA-PLAST RECTAL TIP

    K Number: K843477 · Decision Dec 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    17
    Review Days
    90

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    Basic Information

    Device Name
    PHARMA-PLAST RECTAL TIP
    K Number
    K843477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Zimmar Consulting , Ltd.
    Date Received
    September 6, 1984
    Decision Date
    December 5, 1984
    Product Code
    FCF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCF Instrument, Biopsy, Mechanical, Gastrointestinal

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    Other Clearances by Zimmar Consulting , Ltd.

    K Number Device Name
    K860322 CLINISET INFUSION SET
    K843478 PHARMA-PLAST URIDROP-URIDOME
    K843468 PHARMA-PLAST SUCTION SET TYPE YANKAUER
    K843469 PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-
    K843466 PHARMA-PLAST OXYGEN CATHETER
    K843467 PHARMA-PLAST NASAL OXYGEN CANNULA
    K843470 PHARMA-PLAST CONNECTING TUBE TYPE SUCT-
    K843475 PHARMA-PLAST SINGLE USE OVERSHOES
    K843471 PHARMA-PLAST SYRINGE
    K843473 PHARMA-PLAST INSULIN SYRINGE
    Search all 17 clearances from Zimmar Consulting , Ltd. →