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510(k) Data Aggregation

    K Number
    K151777
    Device Name
    Intradermal Adapter
    Manufacturer
    WEST PHARMACEUTICAL SERVICES INC.
    Date Cleared
    2015-09-29

    (90 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    WEST PHARMACEUTICAL SERVICES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intradermal Adapter is an accessary to a 1ml, ½ inch fixed-needle allergy syringe indicated for use on patients ranging from children 2 year to adults, as a guide for performing intradermal injections.
    Device Description
    The Intradermal Adapter consists of a single injection molded part manufactured from a medical grade polycarbonate. The Intradermal Adapter is a piston syringe accessory which is designed for use with 1mL allergy syringes with ½ inch (27g), (28g), (29g) needles, which are commonly used for intradermal injections given with a traditional Mantoux technique. The Intradermal Adapter has been designed to snap fit on to the end of the syringe forming an injection guide to control the depth and angle of needle insertion exposing only the minimal needle length required to perform a successful intradermal injection. The Intradermal Adapter is provided sterile in an individually packaged configuration.
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