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

    INJECTRITE-C15 AND INJECTRITE-C30

    K Number: K002127 · Decision Dec 29, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    27
    Review Days
    168

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    Basic Information

    Device Name
    INJECTRITE-C15 AND INJECTRITE-C30
    K Number
    K002127
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sterling Medivations, Inc.
    Date Received
    July 14, 2000
    Decision Date
    December 29, 2000
    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 Sterling Medivations, Inc.

    K Number Device Name
    K021530 SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
    K021487 SIMPLICITY EASY ACCESS P INFUSION SET
    K021296 SIMPLICITY QD EASY P INFUSION SET
    K021216 SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
    K021005 SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE
    K020990 SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
    K020912 SIMPLICITY EASY SOFT INFUSION SET
    K020629 SIMPLICITY SIMPLEX SOFT INFUSION SET
    K014062 SIMPLICITY EASY ACCESS INFUSION SET
    K014061 SIMPLICITY STARPLUS SOFT INFUSION SET
    Search all 27 clearances from Sterling Medivations, Inc. →