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

    CORMED HUBER POINT NEEDLE

    K Number: K843083 · Decision Sep 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    CORMED HUBER POINT NEEDLE
    K Number
    K843083
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cormed, Inc., Sub. C.R.Bard, Inc.
    Date Received
    August 6, 1984
    Decision Date
    September 5, 1984
    Product Code
    GAA
    Advisory Committee
    General, Plastic Surgery
    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
    GAA Needle, Aspiration And Injection, Disposable

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    Other Clearances by Cormed, Inc., Sub. C.R.Bard, Inc.

    K Number Device Name
    K863606 BUTTERFLY NON-CORING NEEDLE SET
    K860432 PERCUTANEOUS INTRODUCER KIT
    K854019 PORT-GARD
    K850967 STERILE CORMED MEDIPORT
    K850674 CORMED II AMBULATORY INFUSION PUMP
    K833915 VASCULAR ACCESS CATH. REPAIR KIT
    K823553 CORCATH H & B VASCULAR ACCESS CATHETER