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510(k) Data Aggregation

    K Number
    K991039
    Device Name
    EASYSAFE RETRACTING NEEDLE SYRINGE
    Manufacturer
    SAF-T-MED, INC.
    Date Cleared
    1999-05-21

    (53 days)

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

    SAF-T-MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The primary intended use of the EasySafe® Retracting Needle Syringe is to inject fluid into, or withdraw fluid from the body. The secondary intended uses are: 1. to help prevent sharps injuries when using the product for its primary intended use, and; 2. to help reduce wasted medication when using the product for its primary intended use.
    Device Description
    Not Found
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    K Number
    K973792
    Device Name
    EASYSAFE RETRACTING NEEDLE SYRINGE
    Manufacturer
    SAF-T-MED, INC.
    Date Cleared
    1998-01-29

    (115 days)

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

    SAF-T-MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The primary intended use of the EasySafe™ Retracting Needle Syringe is to inject fluid intramuscularly (IM) into the body. The secondary intended uses are: 1. to help prevent sharps injuries when using the product for its primary intended use, and; 2. to help reduce wasted medication when using the product for its primary intended use.
    Device Description
    Not Found
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