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510(k) Data Aggregation

    K Number
    K980829
    Device Name
    3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
    Manufacturer
    STERIPAK, LTD.
    Date Cleared
    1998-06-02

    (90 days)

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

    STERIPAK, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For respiratory therapy and tracheal lavage
    Device Description
    The subject device is 3 mL Steri-Neb Saline, 0.9% "/v Sodium Chioride Inhalation Solution USP. Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, Steri-Neb Saline is used for dilution of solutions used in nebulizers. Steri-Neb Saline is a unit dose low density polyethylene vial containing sterile, preservative-free, clear, colourless, aqueous solution. The Steri-Neb Saline product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
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    K Number
    K972185
    Device Name
    20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE
    Manufacturer
    STERIPAK, LTD.
    Date Cleared
    1998-03-05

    (268 days)

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

    STERIPAK, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    20mL Normal Saline Topical Solution is usled for moistening and lubricating absorbent wound dressing prior to removal from the wound area.
    Device Description
    The subiect device is a 20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride. It is used for moistening and lubricating absorbent wound dressings prior to removal from the wound area. Normal Saline Topical Solution 0.9% w/v is a unit-dose low density polyethylene vial containing a. clear, colourless, aqueous solution. Normal Saline Topical Solution contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
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