BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

    K Number: K000265 · Decision Jul 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    4
    Review Days
    531

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    Basic Information

    Device Name
    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
    K Number
    K000265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Primary Care Solutions, Inc.
    Date Received
    January 28, 2000
    Decision Date
    July 12, 2001
    Product Code
    JOL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOL Catheter And Tip, Suction

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    Other Clearances by Primary Care Solutions, Inc.

    K Number Device Name
    K082330 PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
    K030813 PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
    K000266 PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION