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    K Number
    K972778
    Device Name
    DEY VIAL SODIUM CHLORIDE 3%
    Manufacturer
    DEY LABORATORIES, INC.
    Date Cleared
    1997-10-08

    (75 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dey Vial Sodium Chloride 3% and 10% are used in conjunction with a nebulizer for the induction of sputum production where specimen collection is indicated.
    Device Description
    DEY-PAK® Sodium Chloride Solution 3% and 10% solutions are contained in a 15 mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.
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