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

    AIMED DISPOS. INJECTION NEEDLE

    K Number: K842230 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    6
    Review Days
    73

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    Basic Information

    Device Name
    AIMED DISPOS. INJECTION NEEDLE
    K Number
    K842230
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tech-Cons Ltd., Intl.
    Date Received
    June 5, 1984
    Decision Date
    August 17, 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 Tech-Cons Ltd., Intl.

    K Number Device Name
    K843117 GREEN CROSS URINARY DRAINAGE BAG
    K843035 SANG-A PETROLATUM GAUZE USP STERILE
    K842228 AIMED FOLEY CATHETER VARIOUS SIZES
    K842255 AIMED SCALP VEIN SET VARIOUS
    K842227 AIMED DISPOSABLE SYRINGE, VARIOUS SIZES