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

    SHARGHP HYPODERMIC NEEDLE

    K Number: K895811 · Decision Sep 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    5
    Review Days
    343

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    Basic Information

    Device Name
    SHARGHP HYPODERMIC NEEDLE
    K Number
    K895811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Shargh Pharmaceutical Co., Inc.
    Date Received
    September 29, 1989
    Decision Date
    September 7, 1990
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Shargh Pharmaceutical Co., Inc.

    K Number Device Name
    K013384 SHARGHP A.V. FISTULA NEEDLE SET
    K895812 SHARGHP INTRAVENOUS CATHETER
    K895980 SHARGHP INSULIN SYRINGES
    K895810 SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE