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510(k) Data Aggregation

    K Number
    K082330
    Device Name
    PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
    Manufacturer
    PRIMARY CARE SOLUTIONS, INC.
    Date Cleared
    2008-10-09

    (56 days)

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

    PRIMARY CARE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement
    Device Description
    This device is USP purified water or saline sealed in 100mL HDPE bottles or 120mL HIPS cups and terminally sterilized using gamma irradiation. All materials are latex free.
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    K Number
    K030813
    Device Name
    PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
    Manufacturer
    PRIMARY CARE SOLUTIONS, INC.
    Date Cleared
    2003-05-30

    (77 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMARY CARE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A sterile water pre-filled syringe for use in inflating foley catheter balloon
    Device Description
    The device is a 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover.
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    K Number
    K000265
    Device Name
    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
    Manufacturer
    PRIMARY CARE SOLUTIONS, INC.
    Date Cleared
    2001-07-12

    (531 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMARY CARE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000266
    Device Name
    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
    Manufacturer
    PRIMARY CARE SOLUTIONS, INC.
    Date Cleared
    2001-07-12

    (531 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMARY CARE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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