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

    IMC PISTON SYRINGES

    K Number: K102969 · Decision Dec 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    11
    Review Days
    75

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    Basic Information

    Device Name
    IMC PISTON SYRINGES
    K Number
    K102969
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Medsurg Connection
    Date Received
    October 6, 2010
    Decision Date
    December 20, 2010
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by International Medsurg Connection

    K Number Device Name
    K110882 IMC INSULIN SYRINGE
    K110656 IMC BLOOD COLLECTION NEEDLE
    K102584 IMC HYPODERMIC NEEDLE
    K100991 IMC SURGICAL DRAPE
    K100846 IMC SURGICAL FACE MASK
    K100208 IMC SURGICAL DRAPE
    K023808 IRRIGATION SETS
    K022159 PISTON SYRINGE & HYPODERMIC NEEDLE
    K014239 MEDSURG EQUIPMENT COVERS
    K971159 SURGICAL DRAPES
    Search all 11 clearances from International Medsurg Connection →