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510(k) Data Aggregation

    K Number
    K993969
    Device Name
    SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
    Manufacturer
    WINCHESTER LABORATORIES LLC.
    Date Cleared
    1999-12-30

    (37 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WINCHESTER LABORATORIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, bruises and minor burns prior to removal from the wound area
    Device Description
    30-ml. polyethylene vial containing Saline Topical Solution, 0.9% w/v Sodium Chloride Solution. Single-use.
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